Understanding the regulatory requirements for successful post-market surveillance of medical devices and IVDs is increasingly important and practical application of the regulations is key to a successful PMS system.
This course will provide a clear understanding of the intention of the requirements, and discuss the responsibilities of the manufacturer, notified bodies and competent authorities. It will also provide advice on where to find useful guidance and will include an insight into some possible PMS methodologies for a range of example medical devices and IVD products, including software.
A review of the reporting and documentation obligations will be included, to enable participants to fully understand and comply with the documentation requirements.
The regulations for PMS under the MDR and IVDR are complex and this course provides an excellent opportunity to gain essential knowledge, practical application and interpretation of the requirements.
Benefits of attending
- Understand the intention of the regulatory requirements for PMS
- Gain knowledge of the available sources of guidance on the subject of PMS
- Practice the setting of objectives and criteria for collection of PMS data
- Explore some possible PMS methodologies for a range of example products covering Medical Devices and IVDs including software
- Learn the reporting and documentation obligations
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Speakers
Karen Pearson,
Active ResearchKaren Pearson has over 30 years’ experience of market research in the healthcare and business-to-business sectors.
Karen started her market research career with IMS, providing market data to the European pharmaceutical sector, before moving on to 3M Health Care, BASF and The Royal Society For The Prevention of Accidents (RoSPA). She started Active Research in 1998 offering a full market research service to pharmaceutical, medical product and business-to-business organisations as well as the public sector.
Active Research focuses on finding practical research solutions that will deliver actionable results for clients, whether that be through, qualitative, quantitative or desk research.
Active Research’s clients include 3M Health Care, Napp Pharmaceuticals, the Cell & Gene Therapy Catapult, Takeda, Kyowa Kirin, Aristo Pharmaceuticals, Lockdown Medical and other leading names in their fields.
Qualifications/Accreditations:
- BA (Hons) Modern Languages
- DipCIM
- MMRS (Full membership of the Market Research Society)
Miss Anne Jury,
Anne Jury Associates LtdAnne Jury is a regulatory affairs consultant with over 25 years experience in the medical and diagnostic healthcare products industries. With a degree in Microbiology, she went to work as company microbiologist for Smith & Nephew Textiles on sterile wound dressing products. Later she went on to work for Notified Bodies, BSI and then TÜV Product Service as a lead auditor covering over 200 medical companies in Europe and USA.
Anne is a member of TOPRA, (The Organisation for Professionals in Regulatory Affairs) and RAPS, (Regulatory Affairs Professionals Society) and a regular speaker at conferences world-wide. Through close association with like minded organizations such as Medilinks, the DTI and NHS Innovations Hubs as well as biotechnology incubators around the UK, she is active in the promotion of integrated management and regulatory systems to assist the successful introduction of new products to market.
Since March 2020, she is also Vice President of Team-PRRC.
Specialties: Technical guidance on regulatory strategies and quality management systems for new medical device product commercialization, including CE marking requirements, implementation of management systems to ISO 13485:2016 and training / coaching in these areas.
Gap analysis compliance audits for manufacturers and subcontract third party auditor for Notified Bodies.
Past visiting lecturer at Cranfield University (through TOPRA) on MScs in Medical Technology Regulatory Affairs.
Vice-President of Team-PRRC, a non-profit association in EU to support those taking on the PRRC role under MDR and IVDR.
Who Should Attend
This course will be valuable to those with an existing knowledge of the regulations who are tasked with PMS, but not sure where to start or who have encountered difficulties obtaining PMS data. Personnel in the following roles and departments will benefit:
- Quality managers within manufacturers
- Quality associates within manufacturers
- Regulatory affairs specialists within manufacturers
- QA/RA responsible people in authorised representatives
- Person responsible for regulatory compliance (PRRC) within manufacturers & authorised representatives (per Article 15 of MDR/IVDR)
