Cath Solutions Inc. recently got a CE mark and is keen to start selling. While trying to register with the health authority, they received a query on PMCF data. Below is a transcript of the discussion that happened between Cecilia, their Regulatory Manager, and Merlyn, the CEO.
- Merlyn (Management): Hey listen, I hear from stakeholders that we do not have PMCF data for our class IIa and some of the implantable devices. What do we do now?
- Cecilia (Regulatory Manager): Umm..We checked all the boxes of PMS activities and produced well-made reports. We should be just fine!
What do you think of the chat above? Do you have the same understanding of ‘being in good shape’ for your product portfolio? Is there a difference between PMS and PMCF?
PMS is a broader term that encompasses all surveillance activities of a medical device’s performance, safety and quality in the post-market phase. PMCF is a specific component of PMS that focuses on collecting clinical data to support long-term performance, safety and quality of the device.
There can be multiple ways of collecting PMS and PMCF data…
We can help you comply with complex requirements of PMS and PMCF for your product portfolio. Our experience lies in preparing/ maintaining the necessary documents for your system and training your resources to meet continuous compliance.
Contact us today at contact@alceonconsulting.com for inquiries. Visit us at alceonconsulting.com to know more about our business.
