When making medical devices available on a market, the authorities want to ensure these devices do what they are supposed to do and they can be used safely. Companies must provide the evidence to demonstrate this and each market has its own ways of creating and presenting that evidence.
Regulatory staff does just that: creating and updating evidence about safety and performance of devices by applying regulatory requirements.
Regulatory requirements are written to fit all possible situations, that means that they require interpretation to be applied to the daily practice. For regulatory staff it can be challenging to do that interpretation for a first time, it takes time to build those routines.
Nowadays companies appreciate their regulatory staff and this is a fast growing profession. That also means there is a need for new staff to learn from experienced older staff. This is the area where Boumans Regulatory Consulting sees their role; sharing 30+ years of experience in medical devices, seen from almost all different perspectives.
Solid regulatory compliance helps ensuring market access, and if this is done in an efficient way, this can create a competitive advantage. In short: smart business management puts priority on regulatory compliance.
- A manufacturer had defined their equipment as reusable for ten times. When setting up their PMS/PMCF plans they decided to annually collect some decommissioned devices back and investigate their specifications. As a result they found some opportunities for improvement.
- A company had initially planned to do the certification transition to the MDR in 2024. Yet, they decided to setup their documentation and PMS procedures in compliance with the MDR from 2021. Recently a new development meant their main device could be updated to a new level of state of the art. They are now in the process of MDR certification and may be able to place their updated device on the market by the end of 2022.