DAkkS: The German Accreditation Body
The DAkkS, the German Accreditation Body, is Germany’s national accreditation authority.
Inhaber der Johner Institut GmbH
Maintenance and service of medical devices
The terms maintenance, preventive maintenance, restoration, inspection, service, and safety inspections are not synonymous. But they all refer to activities in the life cycle of medical devices that serve the objective of ensuring the safety, performance, and effectiveness of these devices even after they have been placed on the market. Manufacturers and operators must meet…
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.
Software 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.
Request 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.
Objective Evidence: Objective evidence in the audit
Laws and standards (e.g., FDA, ISO 13485) require “objective evidence.”
Design 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.
DetailsOperating system compliant with IEC 62304 and FDA?
When selecting an operating system, do medical device manufacturers have to ensure that the operating system is IEC 62304-compliant? What does the FDA say? This article…
Configuration management for medical devices
Configuration management is much more than using version management tools like git or svn. This becomes clear when you look at IEC 62304 and the FDA guidance documents. In this article, you will read about
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