Medical Writer: What this role must accomplish
Medical writers have a firm place in the ecosystem of medical device and IVD manufacturers. This article clarifies
Clinical validation: A definition
The term “clinical validation” is also frequently used in the context of medical devices. For example, the German Federal Ministry of Education and Research (BMBF) has published a guideline on the clinical validation of innovative medical technology solutions (only available in German). The FDA also refers to clinical validation. What is clinical validation? What distinguishes…
DetailsDesign verification of medical products and standalone software
The “design verification” requirement is not just a requirement of the FDA. This article describes what “design verification” means and which regulatory requirements medical device manufacturers should fulfill.
Medical laboratories in the crosshairs of the IVDR. What to do?
The EU’s in vitro diagnostic medical device regulation (IVDR) affects many medical laboratories, although the regulation does not define or use the term “medical laboratory.” Which laboratories are affected? What other laws do the laboratories have to comply with? And how should they ensure compliance with all these requirements? This article provides answers.
DetailsSoftware segregation: 5 objectives you should be aware of
IEC 62304 requires manufacturers to determine the necessary segregation of software components. How this is to be done is not specified in the standard, which leads to much discussion. Find answers to frequently asked questions here.
United Arab Emirates (UAE): Medical devices for an interesting market
The United Arab Emirates (UAE) with its hubs Dubai and Abu Dhabi is one of the most developed economies in the Middle East. The Emirates is among the wealthiest countries in the world. The healthcare system is considered highly developed, which is why the United Arab Emirates (UAE) is a popular health tourism destination in…
DetailsFDA eCopy program
With the term eCopy, the FDA refers to the electronic copy/version of paper-based submissions, e.g., as part of a 510(k) submission.
Device Master Record (DMR): Even for software?
What is a Device Master Record (DMR)? Does software also need a DMR? If so, what are the regulatory requirements in the US and Europe? And what should a DMR contain? This article provides answers.
DetailsRequest for Information: How the FDA is helping with classification
A ‘Request for Information’ can (partially) avoid expensive legal fees. Just ask the authorities directly! This way, you will get a qualified answer, even if it is not free of charge. Read here to find out
DetailsMDR: Software manufacturers take note!
Some Medical Device Regulation (MDR) changes affect all medical device manufacturers. Some of these changes are particularly aimed at manufacturers whose products contain software or are standalone software. Read on to find out what these manufacturers should be aware of.