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).
IEC 60601-1 describes essential performance as performance necessary to achieve freedom from unacceptable risk. This article aims to explain what the standard means by that and how this essential performance differs from basic safety. The article also addresses the IEC 60601-1/AMD1/ISH1:2021 INTERPRETATION SHEET 1.
DetailsManufacturers of substance-based medical devices such as seawater nasal sprays, mucous membrane-soothing cough syrups, or osmotically active laxatives face several challenges once the Regulation (EU) 2017/745 (MDR) came into force: This article illustrates what can be done to overcome the regulatory hurdles and ensure the marketability of your substance-based medical devices beyond the transition periods.…
DetailsIVD medical device validation confirms the device’s medical purpose. IVD medical device verification, on the other hand, proves whether the IVD works as intended. In this article, we provide a five-step guide on how to carry out the verification and validation of your IVD medical devices in a targeted manner and without unnecessary effort. We…
DetailsWhen ANVISA registration is no longer sufficient As a manufacturer, there are some hurdles you have to overcome before selling your medical device in Brazil. The best known is registration with ANVISA. In addition to this, you may also need INMETRO or ANATEL certification for your device. Manufacturers should be aware of the cases in which they must…
DetailsIf you have to conduct a clinical investigation for your medical device or clinical performance study for your IVD, you won’t be able to avoid sample size planning. And you will need to avoid the following two problems when calculating the sample size: Therefore, you need to accurately identify the exact sample size needed so…
DetailsThe same legal requirements apply to the clinical evaluation of software as to the clinical evaluation of all medical devices. This means that as a Medical Device Software (MDSW) manufacturer, you must prepare a clinical evaluation for your product just like any other manufacturer. A performance evaluation must be carried out for software that is an in vitro diagnostic…
DetailsA lot of medical device manufacturers see the international authorization of their device as a potential hazard: the opportunities offered by new markets are offset by hard-to-calculate risks as well as the time and costs required for these authorizations. The five steps presented in this article will help manufacturers to manage these risks better. And this is…
DetailsA Quality Assurance Agreement (QAA) is a contract between companies such as medical device manufacturers and their suppliers (subcontractors). In these contracts, both parties regulate which obligations the suppliers must fulfill regarding the quality of the devices and services supplied. Find out in this article what content a Quality Assurance Agreement should contain and when…
DetailsThe literature search is a key part of the clinical evaluation. It usually involves numerous hours of work. This article will give you six tips to help you efficiently carry out and fully document the literature search. In the literature search, manufacturers gather together scientific articles, among other reasons, to document the state of the…
DetailsISO 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…
Details
Privacy Preference
We need your consent before you can continue on our website. If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission. We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience. Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement. You can find more information about the use of your data in our privacy policy. You can revoke or adjust your selection at any time under Settings.
Privacy Preference
If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission. We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience. Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement. You can find more information about the use of your data in our privacy policy. Here you will find an overview of all cookies used. You can give your consent to whole categories or display further information and select certain cookies.