The post-production phase: Not only relevant for ISO 14971
One of the most common deviations found during audits is related to the so-called “post-production phase”.
The medical device file: What you don’t have to include
ISO 13485 requires a medical device file for each medical device type or medical device family. Many manufacturers think that the medical device file is the same as the technical documentation required by the MDR or IVDR. But that isn’t entirely true. Does one of the three files required by the FDA (DMR, DHF, DHR) match the…
DetailsPost-Market Surveillance plan: Complying with the requirements of ISO TR 20416
With the Post-Market Surveillance plan (PMS plan), manufacturers are trying to achieve two (potentially) contradictory goals. On the one hand, they have to comply with the legal requirements and maximize the safety of their devices. And on the other, they can only take on as much work as they can realistically do in the long…
DetailsDevice category, generic device group, medical device family: Do not confuse them!
The MDR and IVDR use the terms device category and generic device group without fully defining them. ISO 13485:2016 introduces the medical device family. Finally, the MDCG uses the term device range. The definitions of these terms determine the allocation of UDIs and the sampling of product files during certification. Therefore, it is important for…
DetailsHealthcare data security for medical data
Laws such as the Federal Data Protection Act and the Criminal Code make it unmistakably clear that data protection is particularly important in the case of medical data. In this article, you can read why medical data requires special protection, what the special features of medical data protection are, and which data protection laws must…
DetailsAuthorization of medical devices in Japan
The authorization of medical devices in Japan is a big challenge for European manufacturers. But it’s not one they should shy away from, because Japan is one of the 10 biggest markets in the world. This article will tell you about the requirements you have to meet and the best way to overcome the hurdles.
DetailsValidation of machine learning libraries
More and more manufacturers are using machine learning libraries, such as scikit-learn, Tensorflow, and Keras, in their devices as a way to accelerate their research and development projects. However, not all manufacturers are fully aware of the regulatory requirements that they have to demonstrate compliance with when using machine learning libraries or how best to…
DetailsCFDA, NMPA: Approval of medical devices in China
The CFDA, the China Food and Drug Administration, was replaced on September 1, 2018 by the National Medical Products Administration (NMPA), which reports to the Chinese Ministry of Health. This article will provide you with further information on the work and responsibilities of the CFDA/NMPA and the approval of medical devices in China. You will…
DetailsThe FDA’s Safer Technologies Program: Faster access to the US market?
With its Safer Technologies Program (STeP), the FDA hopes to open up a new approval pathway for manufacturers of innovative medical devices. The FDA wants patients to benefit more quickly from these innovations. In this article, you can read about the simplifications and help the FDA intends to provide for you as a manufacturer and…
DetailsAbbreviated 510(k) – When the abbreviation is allowed
Abbreviated 510(k) is one of three 510(k) clearance procedures offered by the FDA. This article tells you,
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