Post-Marketing Clinical Follow-up with Helene Quie (PMCF)
PMCF or Post-Marketing Clinical Follow-Up is a cornerstone of the Medical Device Regulation 2017/745.
This is why I took the opportunity to ask some questions about it to Helene Quie from Qmed Consulting. I met Helene at Medica 2019 in Dusseldorf and she accepted to help the audience to have a better understanding of PMCF.
Helene was part of the podcast episode 40 where we discussed Clinical Evaluation Reports or CER and specifically about the way to prove the equivalence between devices.
PMCF is part of this big box that is PMS or Post-Market Surveillance and this can be a good strategy to start one so you can collect data from the market and use them to prove that your products continue to be safe. This is more important for products that are transitioning between MDD and MDR and which do not have data available.
Who is Helene Quie
CEO at Qmed-consulting – experts in creating value-based documentation for innovative medical devices getting access to the markets through strong and honest partnerships with our clients.
It is my vision to enable better health through close collaborations with large established or newly started medical device manufacturers, small venture based innovative companies, venture funds, notified bodies, hospital, doctors and nurses within a wide range of medical device products and concepts from high-risk complex products such as heart valves with biological tissue to lower risk class products such as dental care products.
I believe that we through our trusted partners and colleagues can change the treatment of sick patients – making sure frontier products reach the patients and end-users, saving patient’s lives.
Together with the Qmed team, I have provided advice and/or operational services for several clients since 2006 within clinical and regulatory affairs, quality management, reimbursement, and health economics and market access with presence through our Qmed team and trusted partners in Europe, US, Canada, India, and Australia.
Links to this episode
- Helene Quie Linkedin: https://www.linkedin.com/in/helene-quie-863a323/
- Qmed Consulting: http://www.qmed-consulting.com/
- MEDICA Video: https://youtu.be/bBC2TwL6HFo
- Episode 40 – CER product equivalence: https://podcast.easymedicaldevice.com/40
- Easy Medical Device Youtube Channel: youtube.com/c/EasyMedicalDevice?sub_confirmation=1