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.
Please note the pages for managers and beginners or filter by keywords (tags).
Medical device and IVD manufacturers must distinguish the concepts of “abnormal use,” “foreseeable misuse,” “errors in normal use,” and “misuse.” This is a prerequisite for understanding and complying with ISO 14971 and IEC 62366 requirements. Even the measures that manufacturers must take depend on the type of use.
DetailsThe Medical Device Coordination Group (MDCG) has drafted a guidance document that describes how manufacturers should place their class 1 medical devices on the market in order to comply with the MDR. The title of the document is “Guidance Notes for Manufacturers of Class I Medical Devices”. This article provides a summary of the document and gives…
DetailsChemical characterization according to ISO 10993-18 is a central component of the biocompatibility evaluation according to ISO 10993-1 and, thus, a prerequisite for the approval of medical devices. It is used to identify unknown substances in medical devices to carry out a toxicological risk assessment. This article provides an overview of
Details“Remediation” is often synonymous with maximum stress: Notified bodies or authorities such as the FDA have discovered significant deviations that must be remedied with the highest priority and without regard to the workload of employees or budgets. This article will help you to complete such “remediation projects” in such a way that
Details
The use of CMR substances is strictly regulated. The MDR also regulates CMR substances and places strict requirements on medical device manufacturers. This article helps to fulfill these requirements.
DetailsIn order to classify their substance-based medical device as such and not as a medicinal product, manufacturers often have to prove that complex ingredients work primarily through physical mechanisms. This article provides assistance.
DetailsISO/IEC 42001 is titled “Information technology – Artificial intelligence – Management system.” The first medical device manufacturers have set out to be certified according to this standard. But are the efforts required to do so justified? Does ISO/IEC 42001 help to meet the requirements of the AI Act? This article provides answers.
DetailsAs part of its “Vision 2030,” Saudi Arabia is planning to expand its healthcare infrastructure. Does this offer medical device manufacturers interesting growth opportunities? And with increased approval requirements, is the effort for approval worth it? Find out in this article how to approval in Saudi Arabia.
DetailsA design change is a change in the design of a product. It is important to understand what regulatory implications arise from this and where there may be an impact on the validity of the product’s declaration of conformity. This article provides an overview and thus resolves many currently common misconceptions.
DetailsThe ISO 15189 standard “Medical laboratories – Requirements for quality and competence” specifies the requirements for a quality management system for medical laboratories. Laboratories are legally obliged to establish a QM system. According to ISO 15189, laboratories that operate in-house IVD medical devices require a QM system, which must be extended by additional chapters. This…
Details