Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
This workshop is sold out. If you would like to receive an email notification when this workshop is offered next, please complete the form at https://raps.realmagnet.land/f2f-2021-eu-workshop-ivdr-leadgen-form.
The date of application is drawing closer and there are no indications that there will be a blanket extension to the IVDR. The IVD sector faces significant efforts to plan for and complete before May 2022 to comply with the new IVDR. The transition from complying with the current IVD Directive to meeting the new IVDR requirements involves significant preparation and report/data generation to be ready for additional notified body review and scrutiny. All stakeholders now have some experience reviewing submissions and there are lessons to be learned to improve your submissions and therefore speed to market.
During this two-day workshop, IVD regulatory experts from various stakeholder groups will share some of this practical experience and top tips with delegates. This is an invaluable opportunity to share experience and gain experience from discussions with experts and peers as we all prepare to comply fully with the new regulations. The workshop will be particularly valuable to all regulatory professionals responsible for achieving IVDR compliance for legacy CE IVDD products, but also new IVDs and CDx intended for the European market.
This workshop sold out very quickly in 2020, so early registration advised.
12 December 2020 – 13 January 2021: Early Bird $650 Member | $750 Nonmember 14 January 2021 – 10 February 2021: Regular: $750 Member | $850 Nonmember
The basics of the IVDR, but with case studies and interactive presentations and discussion.
9:00 (CET) — Welcome and introductions
9:15 (1hr) — 1) How to get started with the IVDR; 2) Key definitions, scopes, placing on the market, putting into service timelines, intended purpose; 3) What do you need to consider before you start preparing files?
10:15 (1hr) — Classification and conformity routes
11:15 (15 min) — Break
11:30 (1 hr) — Software and IEC 62304
12:30 (1 hr) — Lunch
13:30 (1.5 hr) — 1) Technical documentation; 2) The requirements of Annex II
15:00 (15 min) — Break
15:15 (1.5 hr) — 1) The Notified Body process; 2) Application process, audits, ISO v IVDR audit, audit subcontractors unannounced audits, sampling, reference labs, companion diagnostic consultation; 3) NB Q&A
16:45 — Close for the day
A deeper dive into the requirements covering the main IVDR pain points.
9:00 (CET) — Recap day one Q& A
9:15 (1hr) — 1) General safety and performance requirements including risk management
10:15 (1hr) — Practical considerations for implementing UDI ready for the IVDR
11:30 (1.5 hr) — 1) Performance evaluation requirements; 2) Key definitions; 3) Scientific validity and literature searches
13:00 (1 hr) — Lunch
14:00 (1.5 hr) — 1) Economic operators and the role of the PRRC; 2) Post-market surveillance and postmarket performance follow-up including vigilance
15:30 (15 min) — Break
15:45 (1 hr) — 1) Practical considerations for multi-site companies with different technologies; 2) How to project manage the IVDR implementation; 3) Breaking the elephant into bite-size pieces; 4) Communication; 5) Stakeholders; 6) Lessons learned
16:45 (1.5 hr) — 1) Final wrap-up; 2) Discussion Q&A
Sue leads Qserve’s IVD service, she has over 30 years’ experience in the Medical Device and IVD industries including extensive notified body experience.
Key areas of expertise include:
Sue has worked for several IVD companies ranging from start-up to large multinationals, where she has held positions in R&D, manufacturing, and quality assurance. Sue worked for three notified bodies, establishing two from scratch. Sue chaired the European IVD Notified Body Working Group coordinating the notified body responses to the regulations. Sue also participated in the Commission IVD Technical Work Group for many years.
Sue is an experienced trainer on a variety of IVD topics and particularly enjoys creating workshops to improve hands-on experience with the requirements.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and the event title. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.
RAPS will send an electronic letter or a certificate of attendance upon request.
Call RAPS Solutions Center at +1 301.770.2920, Ext 200