What is ISO/TR 20416 about?
ISO/TR 20416 provides guidance on the post-market surveillance process for medical device manufacturers. As manufacturers of medical devices, feedback from users is an important step to evolve your products. ISO/TR 20416 describes a proactive and systematic process that you can use to collect and analyse such data. This feedback helps you to meet the applicable regulatory requirement to gain experience from the post-production activities.
Post-market surveillance is the process by which manufacturers collect and analyze data which can subsequently be used for product realization, risk management, communicating to regulatory authorities, or product improvement. ISO TR 20416 is a new international technical report giving guidance on how best to collect and analyze post-market medical devices surveillance data. 
Who is ISO/TR 20416 for?
PD CEN ISO/TR 20416 on post-market surveillance of medical devices is useful for:
- Medical device manufacturers
- Medical device importers and distributors
- Medical device reprocessors
- Regulatory authorities
Why should you use ISO/TR 20416?
As a manufacturer of medical devices, you would like to be sure that your products are safe and effective. You may also want to keep improving your products. This is possible through user-feedback collected via surveys. Surveillance conducted in a systematic and organized manner can be done using ISO/TR 20416 guidelines.
ISO/TR 20416 enables you to perform such monitoring, by collecting data from the actual use of medical devices, analyzing these data, and then using the information from post-market surveillance in the appropriate processes, such as product realization, risk management, communicating to regulatory authorities or product improvement. And as a result, it maintains throughout the life cycle of the medical device.
ISO/TR 20416 reveals the efficiency, safety, and effectiveness of your medical devices and products. It gives you more information compared to just clinical trial data. ISO/TR 20416 plays a vital role in showing you improvement areas for your products and devices.
