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It is crucial for regulatory professionals to know how to implement the requirements of the EU In Vitro Diagnostics Regulation (IVDR ) within their companies to be assured of obtaining CE marking in time to meet the IVDR deadline.
The format is organized as a workshop on how to fulfill the requirements of the IVDR rather than a presentation of the IVDR requirements and objectives. Roughly 85% or more of the IVD products currently on the market are self-certified and have not been scrutinized by a notified body, but will require notified body oversight for IVDR CE certification. The workshop will look at what we know and have learned since last year, building the new requirements and processes into the QMS to support pre- and postmarket devices, and know the extent of IVDR technical documentation and handling of "legacy data" to successfully assemble a technical documentation file.
The workshop is aimed at professionals who are already familiar with the IVDR and are looking to build practical experience. Participants will benefit from working on challenge exercises and hands on case studies, structured to stimulate discussion and activity on the topic or project.
Pricing Amounts & Deadlines
6/23/2020 -8/14/2020: Early Bird $800.00 Member | $900.00 Nonmember
8/15/2020 – 9/7/2020: Regular $900.00 Member | $1200.00 Nonmember
Objectives
Click here to download the agenda
Speakers
Connie provides guidance for managing the quality and regulatory functions in medical device companies. She has 37 years of experience in the management of in vitro and medical devices manufacturing and their regulation. She has been a Certification Project Manager for a Notified Body for 8 years and continues on contract to perform audits and Technical File reviews. She has performed numerous assessments of non-active and in vitro diagnostic medical device dossiers for safety, performance and regulatory requirements for CE marking. Connie is a frequent ASQ and RAPS speaker and teacher in Quality Management Systems and Regulatory compliance and has a focus on the European IVDR. She is Notified Body / Registrar certified in the MDD, MDR and IVDD European Medical Device Directives, ISO 9001:2015, ISO 13485:2016 and MDSAP and is focused on implementation of the IVDR. She has also taught IVD regulatory compliance at Ohlone College in California and at UC Santa Cruz Extension program.
Dr. Andreas F. Stange is a vice president for the Medical and Health Services group at TÜV SÜD Product Service. He serves as the global responsible for the In-vitro Diagnostic Devices business line. Dr. Stange joined TÜV SÜD in 2001 as medical device expert and had various positions since then in the group. Before taking the current position in March 2017, he was President & CEO of TÜV SÜD in Japan.
Anja Wiersma, is a medical biologist by training with a PhD in the NeuroPharmacological –Behavioural - Physiology field. After working for 8 years at a multinational Pharmaceutical company (Organon), first as scientific researcher and later as a Strategist in Strategy and Business Development department, she started to work for a Notified Body in the field of Medical Devices and In Vitro Diagnostic Medical Devices. She was working for this notified body for 6.5 years. She is fully qualified as a notified body auditor for the Medical Device Directive (MDD 93/42/EEC), Medical Device Regulation (MDR EU 2017/745) and the In Vitro Diagnostic Device Directive (IVDD 98/79/EC) and future In Vitro Diagnostic Device Regulation (IVDR 2017/746). Since 2010 she is a RA/QA consultant for medical device and in vitro diagnostic device manufacturers, and she remains a contractor for several notified bodies executing design dossier reviews and CE audits as well as for executing inspections for independent organisations. Furthermore, as of Jan 2013 until Aug 2015 she was a part time QA/RA director and part of management team of an IVD company in the Netherlands. Since March 2015 she is member in the board of the RAPS Netherlands Chapter. RAPS is the Regulatory Affairs Professional Society. As of March 2017, she is the chair of the board of the RAPS Netherlands Chapter. And as of September 2017, she is a member of the REC as well (RAPS European Council).
Cancellation Policy: All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. RAPS will allow substitutions up to the first day of the event.
Program Contact
Stephany Evans Meeting and Events Specialist Regulatory Affairs Professionals Society® Tel: 301 770 2920, ext. 229 5635 Fishers Lane, Suite 400, Rockville, MD 20852 USA