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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Laws and standards require organizations to prepare a risk management report. Notified bodies and authorities examine these reports intensively because risk management is a key regulatory requirement. Therefore, it is important (not only) for manufacturers to prepare precise, complete, and correct risk management reports. This article provides assistance in this regard.
DetailsSpecial authorizations are a concept of the MDR (Article 59). In this way, the legislator wants to create a possibility to place medical devices on the market in emergency or exceptional cases, even without having gone through a complete or successful conformity assessment procedure. Special authorizations should not be confused with concessions and exemptions under…
DetailsBoth the MDR and IVDR introduce the concept of Common Specifications.
In May 2016, the German version of IEC 60601-1-2:2014 (Edition 4) was published as DIN EN 60601-1-2:2016 with the title “Electromagnetic disturbances – Requirements and tests.” At the end of 2020, a new version of this “EMC standard” – modified by Amendment 1 and called Edition 4.1 – was published.
DetailsThe Health Insurance Portability and Accountability Act (HIPAA) is a US law that establishes requirements for processing protected health data. Institutions that collect or process these data in the USA and their subcontractors must comply with HIPAA if they want to avoid sanctions. For European companies in particular, HIPAA is a regulation that is difficult to understand…
DetailsWe have known how vulnerable IT security is in the healthcare sector since February 2016, when the IT infrastructures of many clinics were brought to a standstill by a simple virus attack. As a result, the authorities are paying closer attention to ensuring that not only clinics but also manufacturers guarantee the IT security of…
DetailsThe regulations relevant to usability engineering require formative evaluations.
The MDR and IVDR require either a “Post-Market Surveillance Report” or a “Periodic Safety Update Report” from medical device manufacturers. The Periodic Safety Update Report is abbreviated as “PSUR”, the Post-Market Surveillance reports as “PMS report”.
DetailsThe MDR requires medical device manufacturers to conduct Post-Market Surveillance (PMS) and thus collect PMS data. This article is intended to help clarify the regulatory requirements manufacturers must consider when collecting these PMS data. Notably, it is intended to highlight whether manufacturers need to consult an ethics committee in Europe if the data arise from…
DetailsBoth IEC 62304 and the FDA require integration tests.
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