Quick Tip: 3 questions to ask about your post-market surveillance process
Ask these 3 questions to evaluate the effectiveness of your post-market surveillance process
The post-market phase is an important part of the overall lifecycle of a medical device. This is because medical devices remain in service for many years after their initial commercialization. It is also not uncommon for them to go through many changes, both in design and manufacturing, in response to the real-world experience related to their safety and effectiveness.
ISO 14971:2019, the international standard for application of risk management to medical devices, has extensive requirements in Clause 10 for activities in the production and post-production phase. The medical device regulation (EU-MDR) also has many requirements for vigilance, surveillance and regulatory reporting during the post-market phase.
Complying with regulatory requirements is certainly important, but that is not sufficient to ensure the effectiveness of your post-market surveillance. The real goal of a medical device safety surveillance system is to become a driver of innovation by enabling an effective, integrated risk management throughout the organization. It is no longer an exercise to simply satisfy regulatory requirements. Signal detection, risk reduction and integration with R&D must become a core competence.
When you focus on effectiveness, and not just on compliance, you deliver substantial benefit(s) to your business.
