Medical Device Post-Market Surveillance (PMS) is a requirement of ISO 13485:2016, ISO 14971:2019 as well as jurisdictional regulations; equally, though, it just makes good business sense. PMS allows the manufacturer to gain greater understanding of how their device is performing once it is on the market and it provides real-life data to support safety and efficacy claims. Furthermore, the manufacturer is able to use the valuable feedback from post-market processes to identify any actual or potential deficiencies, highlight possible areas for improvement, and support decisions to maintain or enhance their product’s quality and patient safety.
This webinar aims to explain what PMS is and identify the responsible parties involved in the data capture and surveillance activities. It will further provide an overview and comparison of regulator expectations when it comes to the main jurisdictions of the US, Europe and Australia. Finally, there will be a discussion on how manufacturers can (and should) use their Quality Management System processes to support the execution and management of PMS activities.
Belinda is an experienced Quality Assurance and Regulatory Affairs Professional in the medical device industry and holds a Bachelor of Mechanical Engineering (Biomedical) (Hons) from the University of Sydney. Belinda has extensive technical understanding and experience in process validation (cleaning/packaging) and sterilisation validation, as well as comprehensive experience in auditing (regulatory, internal, supplier), statistical analysis, and project and risk management.
As the Quality Assurance Manager for PharmaLex Australia, Belinda is responsible for the oversight and overall management of the Quality Management System, whilst also providing external consultation to clients in regulatory compliance and development of Quality Management Systems compliant with ISO 9001, ISO 13485, MDSAP and 21 CFR 820.
Moving to Sydney, Martina held various Regulatory and Quality roles with Australian medical device companies including a packaging and sterilization company, 3D printing company, and a medical device and pharmaceutical consulting company.
Martina currently works as a Medical Device Manager at Pharmalex. She consults with many companies, from start-ups to multinationals, on a wide range of medical devices in relation to regulatory compliance and Quality Management System development. Finally, Martina is currently formalising her several years of learning and experience via completing a Master’s in Medical Technology Regulatory Affairs.