Discover new articles every week on the topics of regulatory affairs (including international approval and FDA approval), QM systems (e.g., ISO 13485), risk management (ISO 14971), software development (IEC 62304), IT security, clinical evaluation, usability engineering (IEC 62366-1), and systems engineering (including IEC 60601-1, ISO 10993) - also for IVD medical devices.
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The NIS-2 (Network and Information Security) Directive is a European directive (Directive (EU) 2022/2555) that sets minimum standards for cybersecurity within the EU. Does this directive also affect IVD and medical device manufacturers? If so, what does it require, and what should manufacturers do? This article provides answers.
DetailsThe requirements for clinical investigations to evaluate a device have increased enormously under the MDR. Learn the most important things you need to know about the regulatory pathway for clinical investigations under the MDR here.
Laws and standards (e.g., FDA, ISO 13485) require “objective evidence.”
The NMPA Usability Guidance affects many manufacturers of medical devices and IVDs, as well as manufacturers of combination products, who want to market their products in China. This article clarifies which devices must comply with the NMPA requirements regarding usability and what these requirements are.
DetailsMost medical device manufacturers associate the term “design validation” with the FDA. However, not only the FDA but also European regulations, particularly ISO 13485, require design and development validation. Nevertheless, design validation and validation of the design should not be confused. This article shows how the two differ and which regulatory requirements must be observed.
DetailsThe Medical Device Single Audit Program (MDSAP) was initiated to satisfy a wish of many medical device manufacturers: To replace the various audits and inspections by authorities from different countries with one audit. Participating in the MDSAP shall suffice for verifying effectiveness and conformity of QM systems (e.g., with ISO 13485 or 21 CFR part 820). In…
DetailsWhen selecting an operating system, do medical device manufacturers have to ensure that the operating system is IEC 62304-compliant? What does the FDA say? This article…
Configuration management is much more than using version management tools like git or svn. This becomes clear when you look at IEC 62304 and the FDA guidance documents. In this article, you will read about
DetailsWith the Pre-Submission Program (“pre-sub” for short), the FDA offers a formal procedure for manufacturers to clarify their regulatory strategy and specific questions before actual approval or market clearance. A pre-sub request is suitable in the preparation of 510(k)s, De Novo Requests, or PMAs, among other things. This can avoid unnecessary costs and effort on…
DetailsWith the eSTAR Program, the FDA aims to increase the efficiency of approval procedures (e.g., the 510(k) procedure) through digitalization. The Johner Institute is working with the FDA on the further development of eStar. This article tells you how forward-looking this approach is and whether you should or even must take part.
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