FDA 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.
NIS-2 on cybersecurity: It’s probably affecting you!
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.
DetailsClinical investigations of medical devices under the MDR – The regulatory pathway
The 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.
Objective Evidence: Objective evidence in the audit
Laws and standards (e.g., FDA, ISO 13485) require “objective evidence.”
NMPA Usability Guidance: How to fulfill the requirements
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.
DetailsDesign validation: What you need to demonstrate
Most 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.
DetailsMDSAP: Medical Device Single Audit Program
The 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…
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