The FDA Center for Devices and Radiological Health (CDRH), which is also responsible for medical devices, has published tips on how to comment on guidance documents issued by the CDRH. What does it say?
Changes in the Notified Body Postion Paper on Hybrid Audits
End of January 2023 you could already read about a 3.5 page position paper from Notified Bodies regarding their perspective on hybrid audits of medical device and IVD manufacturers. The position paper has now been updated.
How to create a Notified-Body-compliant Technical Documentation
One of the most important documents in the context of medical device regulation is the technical documentation. Recently updated to version 2, a helpful position paper from Team Notified Body serves as a best practice guide on this topic. Read more here.
How to create a Notified Body compliant Technical Documentation?
One of the most important documents in the context of medical device regulation is the technical documentation. Updated as version 2, a helpful position paper from the Team Notified Body provides assistance in this regard as a best practice guide.
Dealing with Artificial Intelligence in the Context of the further Development of Software in Medical Devices
The topic of artificial intelligence/machine learning (AI/ML) is currently all around. The FDA has also taken up AI/ML and published various draft guidance documents. A current draft is aimed at manufacturers of medical devices that contain software.
FDA publishes Lists of planned Medical Device Guidances 2023
In October 2022, the Center for Devices and Radiological Health (CDRH) published a list of new guidances planned for fiscal year 2023 (1 October 2022 - 30 September 2023), as well as older guidances to be reviewed for topicality. What is planned?
Medical Device Warning Letter Statistics for Fiscal Year 2022
The ECA regularly analyses the deficiencies identified in FDA Warning Letters relating to medical devices. Since medical devices can also be part of a combination product of a medicinal product and a medical device, these statistics are also of interest to manufacturers of these products. What do the medical device Warning Letter statistics show for the 2022 fiscal year?
You could already read in the past about the FDA CDRH's website for medical devices. It provides you with the possibility to get familiar quickly with the topic "medical devices" or to stay up to date. What is new?
Medical Device Information available on EMA's Website
We have already reported about information regarding medical devices available on the EU Commission's website. Recently, a chapter on in vitro diagnostics (IVDs) was added. Also, the EMA website has a dedicated page for medical devices. What can be found there?