IMDA Update. IMDA sets out ambitious vision for the medtech sector in Ireland

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1 December 2015 IMDA sets out ambitious vision for the medtech sector in Ireland Contents Page 02/03 IMDA launch priorities for the next government Finance Bill will complement Budget 2016 Ibec launches national general election campaign Companies must now prepare for MDR and IVDR Page 04/05 Finalists for Medtech Awards highlight Ireland s role as a global leader Irish Medtech CEO Forum 2015: Joining the dots to connect health Over 100 regulatory and quality affairs professionals participate in IMDA forum Three new lean mentoring partnerships announced Page 06/07 IMDA visit to Fraunhofer Institute Herizon: A new event for professional women Events and Training Members News IMDA has set-out the sector s priorities for the next government in a major new document. The healthcare system faces similar pressures to other European countries, trying to meet higher demands with fewer resources. By investing in a modern healthcare system, innovation can drive efficiencies and deliver better patient care. Other areas highlighted include, making sure students get the right skills needed to get jobs and measures to encourage entrepreneurs to start-up new businesses. One of the sessions for this year s Irish Medtech CEO Forum, jointly hosted with Enterprise Ireland and IDA Ireland, will explore ways to help more small business make it big. The next phase of the IMDA and Enterprise Ireland Mentoring Programme will be launched with insights from participants of the first programme. Another exciting session will explore the day s theme Joining the dots to connect health. As the sector grows, we re entering a new age of innovation with new opportunities for collaboration with ICT. Later during the day, Thursday 10 December, the Irish Medtech Excellence Awards, will see 10 finalists compete across three categories: Medtech Company of the Year Award, Emerging Medtech Company Award, and Academic Contribution to Medtech Award. This event recognises the strength of the sector in Ireland, and the companies which make it internationally recognised. We will also see Enterprise Ireland and Cleveland Clinic jointly give the award for clinical innovation. The new year will bring a number of developments, events and opportunities. IMDA are pleased to announce that following great progress by members, the best practice in product development model is expected to be launched in early This has been in development for considerable time and thanks to industry which has made significant inputs to progress this project. For the first time, the Global MedTech Compliance Conference will be held in Dublin. This follows work from IMDA to develop a new outreach campaign on the group s code of ethics. The industry in Ireland is committed to operating to a high standard in a transparent fashion. Lastly, we will be launching the new IMDA Strategy in February. This important piece of work looks at global trends and new avenues for growth. We would not have been able to bring this important piece of work together without the commitment from the IMDA board and inputs from the wider membership. Donal Balfe Medtronic IMDA Chairman

2 IMDA launches priorities for the next government Finance Bill will complement Budget 2016 IMDA launched the measures needed to maintain Irish competitiveness in a major document on the sector s priorities for the next government Innovating for Ireland s future health and care, driving economic growth in the medical technology sector. IMDA have identified six priority areas: Make Ireland s healthcare infrastructure world class by adopting the latest information systems, newest innovations, and best in class business models. Promote a culture of innovation leadership within the Irish healthcare system by rewarding clinical research underpinned by world class facilities. Incentivise clinical-industry engagement to support commercialisation of novel innovations. Reduce healthcare costs by adding value by changing the procurement process to promote long-term results over short-term costs and ensure SMEs can engage in the tendering process. Help medtech business win by ensuring the Knowledge Development Box supports different ways of generating intellectual property, leverage Ireland s strong IT and medtech sectors to commercialise new technology based health solutions and establish an industry-led advanced manufacturing research and technology institute. Reward risk taking to encourage new medtech start-ups by reforming capital gains tax and share option schemes to make Ireland a start-up hub. Equip people with the skills needed by making sure that higher education institutes equip students with the skills needed to gain jobs and promote entrepreneurship at second level. Like many countries, Ireland s health system faces the challenge of dealing with increased pressures with limited resources. But there is now an opportunity for the next government to build a world-class healthcare system to attract more clinical research into Ireland. Ireland should maximise opportunities with growing demands to become major contributors to global healthcare and the global economy, and build on the momentum to establish Ireland as a world leader within the medtech sector. For more information, please visit Ibec Director of Policy Fergal O Brien The Finance Bill will facilitate further business growth and development. The removal of the USC liability for employer contributions to PRSAs will remove an impediment to pension provision in the private sector and introduce a level of fair treatment in the area. In addition, the changes made to the taxation of expenses of non-executive directors makes practical sense and will help Irish firms expand the experience and diversity of their boards. Given Ireland s position as a small country with a smaller core of possible non-executive directors, changes in Finance Bill 2015 will be beneficial to the growth and good governance of the domestic enterprise base at little or no cost to the exchequer. 71% of companies to award pay rises next year Ibec published the headline results of a comprehensive new survey, which found that 71% of companies plan to increase basic pay next year, The overview of survey results shows that next year, the median pay increase is expected to be 2%, similar to levels reported in 2014 and The total pay bill in 2016 is expected to increase in 67% of companies, similar to this year. This is due to pay rises and new hires. As many as 87% of high-tech manufacturing firms plan to increase basic pay in With unemployment still unacceptably high the focus must remain on job creation. IMDA Sterility Assurance Forum brings sterilisation experts together Almost 50 sterility assurance professionals were in attendance at this second meeting of the group in Richard Cowman, Synergy Health, updated delegates on the recent regulatory developments relating to several ISO sterilisation standards. This was followed by an update on the MDD Revision provided by John O Dwyer, Teleflex Medical. Moving to specialised technical topics, Marie Coyne, Abbott Vascular, presented on assessing product experience when transferring ethylene oxide processes which was followed by a presentation by Richard Cowman on cycle calculation for ethylene oxide. The afternoon session began with a Business Continuity Planning Workshop facilitated by David O Sullivan, DePuy Synthes. The meeting wrapped up with open discussion on the recent decision of the French regulator on ethylene oxide residual levels and the impact for medtech companies supplying product into this market. The next Forum meeting will take place during Q

3 Ibec launches national general election campaign Companies must now prepare for MDR and IVDR Ibec recently launched its national general election campaign which sets out key priorities for the next government. All political parties need to recognise the intrinsic link between a successful business community, job creation and a thriving economy and society. Ireland s attractiveness to corporates, entrepreneurs and mobile talent will determine our ability to improve the quality of life of all our citizens. High unemployment remains an acute problem and one that only business can solve. Over the coming weeks and months, Ibec will roll-out a major national print, online and social media campaign, host a range of events around the country and launch detailed policy proposals to address some of the big challenges facing the country. To find out more about Ibec s Business Manifesto, visit The final of five trilogue meetings between the European Parliament, the European Commission and the European Council will take place in early December. The Council s General Approach on the draft Regulations was agreed at an EPSCO Council meeting in October. It s expected that much of the current draft text will be present in finalised legislation: regulatory changes will be extensive and are expected to vary at product level with impacts on organisational Quality Management Systems. Concerns for industry continue to surround the topics of scrutiny, clinical investigations for class III and implantable devices, up-classification of selected devices, labelling of product/ sales package, IFU s and technical documentation. With regard to the draft IVD Regulation, the debate is being overshadowed by the topics brought forth in the MDR. Industry foresees a real danger that decisions will be made without discussing or understanding the impact for patients and the IVD sector. In Brussels, EMDA continue to closely monitor trilogue negotiations. Companies are advised to prepare for the new Regulations now as it is clear that a wide range of business functions will be impacted (R&D, operations and supply chain, quality assurance, vigilance and surveillance, commercial and others). Pictured at the launch: Director at Glenisk, Gerard Cleary with CPL Resources CEO Anne Heraty and Ibec CEO Danny McCoy Invitation to IMDA AGM, 10 December, Dublin Members of IMDA are invited to IMDA s AGM, taking place on the 10, Dublin. The AGM provides an opportunity for members to learn about the work of the association over the past year, and future priorities of same. IMDA Statement of Strategy will also be presented at the AGM, and members will have an opportunity to provide feedback. The strategy will be formally launched in early For more information, please visit /events MedTech Europe votes to phase out direct sponsorship At the MedTech Europe AGM in December, IMDA joined other national associations in voting for a new code of ethics which would bring together the Eucomed and EDMA s code of ethics. One of the key recommendations, which will take effect by 2020, was phasing out of direct sponsorship for third party conferences and establishing more stringent rules for educational grants. In Ireland, IMDA is rolling out a new outreach campaign with an informative video. For more information visit /ethics. IMDA meeting with Department of Health IMDA met with the new Deputy Secretary in the Department of Health, Pat O Mahony, who has responsibility for Governance and Performance across the entire health sector. IMDA used the opportunity to discuss our priorities for government and our own Strategy for The discussion also included importance of health interactions between hospitals and industry representatives, and how IMDA might engage further with relevant stakeholders to build awareness of the pending changes to the new Code of Ethical Business Practice. Global MedTech Compliance Conference comes to Dublin in 2016 The 2016 Global Medical Technology Compliance Conference, will take place in the Convention Centre, Dublin, Ireland, May The conference will be jointly hosted by AdvaMed and MedTech Europe in conjunction with the Irish Medical Devices Association. This is the first time this major conference will be held in Ireland. The event aims to promote the understanding, development, and promotion of ethical compliance at the most senior level in medtech sector. This conference provides an opportunity to examine the importance of ethical practices between healthcare professionals and our industry. To find out more, visit: 3

4 Finalists for Medtech Awards highlight Ireland s role as a global leader Irish Medtech CEO Forum 2015: Joining the dots to connect health The Irish Medical Devices Association, Enterprise Ireland and IDA Ireland recently announced the finalists for the Irish Medtech Excellence Awards It s been nearly ten years since the awards were first held and in that time the Irish medtech sector has positioned itself as a global leader for the industry with 18 of the worlds top 25 medtech companies operating here. This year s finalists reflects the high level of Foreign Direct Investment as well as the ambition of Irish start-ups. Academic partnerships are playing an increasingly important role which is why they are recognised in the awards. The shortlist is: Medtech Company of the Year Abbott Diagnostics Longford Boston Scientific Stryker The Tech Group Emerging Medtech Company Award AventaMed Incereb SurgaColl Academic Contribution to Medtech Biomedical Diagnostics Institute, Dublin City University UCC BioDesign University of Limerick, Department of Mechanical, Aeronautical and Biomedical Engineering The finalists for this year s Irish Medtech Excellence Awards exemplify how Ireland s medtech sector became the highest employer in Europe, per capita, and why medical technology developed here is exported to over 100 countries. The Irish Medtech Excellence Awards ceremony will take place in the Clontarf Castle Hotel, on Thursday 10. The awards are sponsored by KPMG, Teleflex, SteriPack, AIB and IMDA Skillnet. For more information, please visit /awards. We are delighted to be in Dublin for the first time, for the ninth Annual Irish Medtech CEO Forum which is jointly hosted by Enterprise Ireland, IDA Ireland and IMDA. As the medtech industry continues to rapidly evolve, while facing policy challenges, it s vital to tap into the experience of thought leaders from across the world to learn from their successes. Companies in the sector face challenges and opportunities on many fronts, in particular from healthcare spend, changing market dynamics, new fiscal and economic policies, the emergence of technology enabled devices to new manufacturing practices and much more. Speakers will provide their perspectives on how business models have adapted in light of new opportunities in an environment where the number of markets, players and payers is growing. This year s conference is organised around the following four themes: The evolving global medtech business model Global economic and financial environment Supporting entrepreneurship, IMDA Enterprise Ireland Mentoring Programme Launch Joining the dots to connect health We would like to thank all of the speakers and our sponsors: Platinum sponsors: KPMG; Gold sponsors, Teleflex Medical, SteriPack, and AIB; as well as Silver Sponsors IMDA Skillnet. Showcasing medtech to over 1,000 students at BT Young Scientist IMDA is looking forward to another good year at the BT Young Scientist and invite member companies to join us on the Ibec stand 5-8 January 2016, in the RDS, Dublin. This event earlier this year was the largest exhibition to date with 1,174 students, 546 projects participated and over 59,000 visitors. If you want to make sure that your company has the right skills in the future this is a unique opportunity to inspire students and educate them about the value of medtech. Member company participation is an important part of our success at the event. If you are interested in getting involved, please ciara.finlay@ibec.ie. IMDA apprenticeships move to the next stage Following on from IMDA s approval for the medtech apprenticeships, a further submission was made to the Apprenticeships Council in October, outlining the next steps for implementation. IMDA have formed an Apprenticeships Steering Committee which has set an ambitious target of September 2016 for roll-out of the new apprenticeships. We are now awaiting information from the council in respect of our development plan and allocation of funding. 4

5 Over 100 regulatory and quality affairs professionals participate in IMDA forum Three new lean mentoring partnerships announced More than 40 IMDA member companies participated in IMDA s Quality and Regulatory Forum in Galway The meeting was chaired during the morning by Robbie Walsh, Boston Scientific. Dr. Joachim Wilke, Sr. Manager Regulatory Affairs & Policy Europe, Regulatory Affairs EMEA, Medtronic GmbH and Vice Chair Eucomed Regulatory Affairs Committee provided an update on the MDD Revision, trilogue status, points of debate and industry impact during the session. Susan Murphy, European Medical Device Operations Manager, NSAI followed with a Notified Body perspective on the new Regulations. Member companies were advised to start to prepare for regulatory changes by Lynn Heaver, Director Strategic Regulatory Affairs - Outreach UK/ Ireland, Johnson & Johnson Medical Ltd, who discussed compliance and impacts on business functions such as R&D, operations and supply chain, quality assurance, vigilance surveillance and commercial. Geraldine Finn, Vice President of Regulatory Affairs, Coronary and Structural Heart, Medtronic followed with an industry perspective on the US healthcare environment, FDA strategic priorities and performance, post approval submissions, combination products and 510(k)s. The afternoon session was chaired by Pamela Mackey, Bausch & Lomb. Susan Murphy, NSAI, looked at changes coming down the line for the ISO standard. Rita Gleeson, Validation Manager, Stryker Ireland presented on successful process validation and what companies can do to ensure ongoing improvement of their own process validation processes. The afternoon session was wrapped up with a presentation by Pauline O Flanagan, IMDA Skillnet Manager who identified opportunities for bespoke programme development for the medtech sector and IMDA Skillnet QA/RA offerings in Among these will be the development of a new Essentials in Regulatory Affairs conversion programme to enable quality and technical specialists in industry to move rapidly into a regulatory business function. IMDA look forward to continuing successful QA/RA Forum meetings in Following on from the success of the Waters Technologies and Lake Region Medical Pilot, IMDA have received numerous requests for lean mentoring from members companies. As many as 14 companies have requested lean mentoring since the IMDA Manufacturing Conference was held in April. The recent showcase presentation of partnership at the European Shingo Conference in October has further driven demand for this innovative programme. We are delighted to say that three new partnerships have been established with a number of other partnerships ready to commence. The following six companies will provide updates on their progress at each quarterly meeting of the IMDA Op Ex Working Group. KPW Print and Abbott Diagnostics Longford Gilead LifeSciences and DePuy Sythes Tecomet and Boston Scientific Cork We are pleased that the scope for partnerships has expanded to reflect interest from other sectors. The cross-sectoral linkages have been formed thanks IMDA s work with our colleagues in other Ibec groups. We are now seeking lean mentors, to fulfil this demand from industry and welcome support in this great initiative. If you would like to become a lean mentor, please contact: adrienne.mcdonnell@ibec.ie Nearly 200 now trained in MÓR TM Model Nearly 200 people have now undergone training on the MÓR TM Model. IMDA will survey members in January 2016 to gauge usage and implementation levels. This survey will be used to substantiate the application for the Irish Institute of Training and Development (IITD) Awards in Further improvements to the model have been made recently and the new model will be issued to all members who have undergone training. This will be supplemented with a new MÓR TM Model video which both promotes the mode and assists companies who wish to bring the model back to their plant and to roll-out after the training. A new group discussion forum has also been launched on the IMDA website to allow members to interact with other users and problem-solve. IMDA best practice in product development model to be launched Following extensive discussions during the course of 2015, IMDA s industry expert group, which includes members from Creganna Medical, Bausch & Lomb, Boston Scientific, Aerogen, Steripack Ltd, Neuravi, Siemens Healthcare Diagnostics, Incereb and Stryker, have significantly progressed IMDA s best practice in product development model. The model will be launched in Q The model scope focuses on activities best described by sections TRL2-TRL6 of the Technology Readiness Levels Continuum (from concept to prototype). MÓR TM Model Standard The format and criteria for the new MÓR TM Model Governance Panel, and the assessors panel has been established. Invitations will be issued to Governance Panel members, and Assessors will be issued in January

6 IMDA IMDA visit to Fraunhofer Institute Events and Training IMDA s Next Generation Manufacturing Group has arranged a visit to the Fraunhofer Institute in Stuttgart s Advanced Manufacturing Centres and IAO which will take place in February Lufthansa Technik and Allergan driving Op Ex through lean leadership This visit will assist members by building their understanding of new technologies and processes in advanced manufacturing. An emphasis will be placed on the factory 4.0 and additive manufacturing. IMDA s Next Generation Manufacturing Group is also working closely with IDA Ireland to assist them in their quest for establishing a centre for Advanced Manufacturing Excellence in Ireland. They currently have two pilot lines in place in Ireland on both priority areas. On 11 November, 12 companies in addition Enterprise Ireland and Beaumont Hospital participated on an immersion day hosted by Allergan Pharmaceuticals as part of the 2015 IMDA Skillnet Lean Leadership programme. Previously, a session on Value Stream Mapping was hosted by Lufthansa Technik Turbines, Shannon. The 2016 Lean Leadership programme is planned to start in March next year. Medtech: ReCreate seeking unwanted material to create art Continuing our support for Irish Year of Design 2015, we would like to inform members about Recreate, a national social enterprise that takes end of line and surplus stock from businesses and reuses them as arts materials. ReCreate ensures these materials are affordable to early education providers, schools, youth, community and arts groups and others nationwide. For businesses, ReCreate reduces the costs of moving on end-of-line materials, which make great art materials such as plastics, tubing, foam and much more. Visit contact Dara Connolly, Executive Director dconnolly@recreate.ie Herizon: A new event for professional women IMDA and Plastics Ireland host members evening as part of the StartUp Gathering Over 100 members attended the members evening jointly hosted by IMDA and Plastics Ireland, on the 06 October in Sligo. Start-ups and larger companies heard about the cutting edge BioInnovate programme, fostering entrepreneurship in our schools, the first competency training research centre for HCP s (ASSERT), what CEOs need to know about cybersecurity and the new IMDA and Plastics Ireland apprenticeship programmes. Irish women make and control the spending of billions of euros every year. Herizon is a new event for them, it will take place April 2016 in the RDS Simmonscourt, Dublin. Over three days there will be 30 talks and 70 experts on topics such as technology, jobs and start-ups etc. Women wield massive economic power: 846,000 of the workforce is made up of women 80% of healthcare and pharmaceutical purchases are made by women 45% of customers who switch health insurance providers are women Despite this, many events designed to bring brands and women together fail. That s why Herizon is taking a new approach. To find out more, info@herizon.ie or visits 6 New Op Ex Chairman announced IMDA s Op Ex Working Group had their year-end meeting on 19 November in Boston Scientific Galway. The New Chairman for the group is: David McKernan, Teleflex Medical; and vice-chair is James Browne, Waters Technologies. The group is planning a strategy day in February 2016, to develop their new charter, and determine the strategic focus for the next four years.

7 Members News Seabrook Technology Group announced its partnership with Siemens Industry Software in Ireland and the UK last month. The partnership is expected to generate revenue of over 1 million Euro in the first year to eighteen months for Seabrook. It will lead to the creation of eight new high-level jobs, six at its Cork offices and two in the UK. Vornia Limited will be moving premises to a new facility in December, to Synergy Centre, Laboratory C, Institute of Technology, Tallaght, Dublin 24, D24 A386. These are exciting times for Vornia and we look forward to continuing to work with our suppliers, customers and partners as we move into the new year. Neuromod Devices Limited recently raised 5.5 million in funding from Fountain Healthcare Partners. The investment will be used to further enhance scientific and clinical understanding of its bi-modal neuromodulation device, mutebutton, and commence US clinical trials of the device. This marks a significant milestone for Neuromod and brings the total raised by the company to-date to over 8 million. In September 2015 Incereb Ltd. successfully achieved 5-10-k certification for the NEON EEG range of devices - these already held the CE mark and are for use on neonates in NICU s. The products are now being distributed via a network of international distributors. Jim Roche CEO said these are exciting times; FDA certification is a significant milestone in our corporate history and has opened up a key target market for our products. The NEON range is 100% manufactured in Ireland. S3 Group which delivers Connected Health solutions at scale to leading Pharma, medical device and healthcare providers has been awarded the ICT Exporter of the Year 2015, by the Irish Exporters Association. System Label selected as finalists in this year s Irish Print Awards for the categories: Print Business Innovation; Screen Printing; Print Finishing. The organisation entered the Incereb foam sensor pad. Aerogen has received the Zenith Award from more than 400 suppliers, as voted for by over 52,000 respiratory therapists and allied health practitioners. The award was given in recognition of its breakthrough vibrating mesh technology, service excellence, truth in advertising and commitment to the respiratory care profession. Aerogen s innovative mesh technology is used by over 60% of the Top 100 hospitals in the US to deliver aerosol medication in the acute care setting. Automatic Plastics recently exhibited at MedInIreland 2015 organised by Enterprise Ireland. Al Lawless (MD) met with companies from Australia, Switzerland, Germany, UK, USA, France and Belgium. The company is now progressing a number of potential new projects with an emphasis on Design For Manufacture (DFM). BioInnovate Ireland is a forum which combines resources to catalyse and lead Medical Innovation by: Delivering the next generation of specially trained entrepreneurs Identifying new product development opportunities Developing and proposing commercial opportunities to move an identified clinical needs forward Provide and spin out companies in collaboration with clinicians and partnering companies Building a medtech innovation ecosystem that can deliver internationally BioInnovate offer two core programmes of activity The Fellowship Programme and the Industry Training Workshops. BioInnovate are currently recruiting for the 2016 Fellowship year. To register interest, visit or contact Paul Anglim at paul.anglim@nuigalway.ie or at In October, AbbVie Ballytivnan has received certification for ISO from Certification Europe. This site achievement can be credited to the exceptional leadership and culture of teamwork and responsibility that can be found in Ballytivnan. The site s Energy Team was instrumental in establishing systems and achieving the certification as they will play a key part in its future success. This certification will help the site reduce energy consumption and greenhouse gas emissions. Trend Technologies were recently recognised with the Medium Size Exporter of the Year award. Trend had to beat off competition from over 70 entries to win this prestigious award. Trend s success in delivering real value and exceptional service to our customers has seen our exports grow by 100% in the last four years. Shannon MicroCoil are now offering a new range of guidewires, from.014 to.040 in diameter in both coated and uncoated finishes, were recently launched. It operates to extreme diameters and are ISO13485 certified. It operates a rapid prototype or sample production which facilitates R/D Engineers involved product development. PMD Solutions, an SME based in Cork, will receive 4.2 million in funding from the latest round of Horizon 2020 SME Instrument (Phase 2) to develop a new respiratory monitoring device to improve patient outcomes. RespiraSense the world s first continuous and accurate discrete sensor measures the mechanics of respiration, it is currently used in hospitals in Ireland (Galway University Hospital and Cork University Hospital as of December 1st), Germany, and Hong Kong. By the end of 2015 PMD plans to be actively used in 5-10 hospitals around the world. 7

8 nk Keane alograph (Ireland) IMDA Who we are Board Members Board Members IMDA Executive Team Barry Comerford Cambus Medical John O Dea Crospon Dr Sinéad Keogh Director IMDA Chairman Donal Balfe Medtronic Ciaran Corcoran Abbott Diagnostics, Longford Bill Doherty Cook Ireland Damain Finn Bausch + Lomb Michael O Reilly Phillips-Medisize John Power Aerogen Connor Russell Boston Scientific Clonmel Dr Áine Fox Senior Executive Adrienne McDonnell Senior Executive Ciara Finlay Executive Rory McMahon Intern IMDA Vice-Chair James Winters DePuy Synthes Conor Hanley ResMed Frank Keane Vitalograph (Ireland) Tony Kennedy Teleflex Medical Dr Patricia Smith Former CEO BMR David Tallon Stryker Phil Watson SteriPack Dr Enda Dempsey IMDA Skillnet/Springboard Executive Pauline O Flanagan IMDA Skillnet Manager Michelle Reinecke-Quain Executive Support for IMDA Skillnet FOLLOW IMDA on Why not follow us on Twitter? Upcoming IMDA Events Ibec Annual Lecture Ibec 2 December 18:00-21:30 IMDA Board Meeting Dublin, Clontarf Castle 10 December 9:00-11:00 IMDA/EI/IDA CEO Forum and Awards Clontarf Castle 10 December Hackathon for Medical Technologies - Focus on the Patient and User Dublin 15 December 9:00-17:00 IRCA Internal Auditor Ballybane Enterprise Centre 25 January 9:00-17:00 IRCA Lead Auditor Ballybane Enterprise Centre 27 January 9:00-17:00 Process Validation Ballybane Enterprise Centre 11 February 9:00-17:00 IMDA Board Meeting 11 February IMDA Skillnet Steering Committee Meeting 18 February 9:30-14:00 Statistics with Minitab Training Point, Raheen 2 March 9:00-17:00 IMDA Op Ex Meeting Vistamed, Carrick-on-Shannon, Co. Leitrim 9 March IMDA Sterility Assurance Forum April Medtech and Engineering IR/HR Forum, Galway 8 September IMDA Skillnet Steering Committee Meeting 28 April 9:30-14:00 Statistics with Minitab Galway Technology Centre 8 June 9:00-17:00 IMDA Op Ex Meeting Nyrpo Healthcare, Waterford 15 June IMDA Skillnet Steering Committee Meeting 14 July 9:30-14:00 IMDA Op Ex Meeting Abbott Diabetes, Donegal 7 September Medtech and Engineering IR/HR Forum, Galway 8 September IMDA Skillnet Steering Committee Meeting 22 September 9:30-14:00 IMDA Global Access QA/RA Medtech Conference October IMDA Op Ex Meeting Teleflex, Athlone 29 November IMDA/EI/IDA Annual Medtech CEO Forum Galway () 08 December Irish Medical Devices Association Lower Baggot Street, Dublin 2 Telephone: Website: 8