The most frequently asked questions about the quality management system
This FAQ provides answers to the most common questions that companies such as medical device manufacturers have about quality management systems (QM systems) and ISO 13485.
Let service providers take care of risk management?
Outsourcing risk management to service providers. Wouldn’t that be convenient? But is that allowed? And how much sense does it make anyway? Conversely, what should you as a service provider not be burdened with under any circumstances? This article provides the answers. It suggests how manufacturers and service providers can divide their activities and gives…
DetailsSBOM: Software Bill of Materials
Laws and standards require medical device manufacturers to compile a Software Bill of Materials, the SBOM. However, standardized SBOM formats are not always sufficient to meet these requirements. In particular, medical device manufacturers who do not supply and use SBOMs for their software are no longer accepted in the market. Here are the reasons.
DetailsSoftware life cycle: What is meant by this?
The Medical Device Regulation (MDR) (like the Medical Device Directive (MDD) and thus the Medical Device Act before it) requires manufacturers to comply with life cycle processes for their software. IEC 62304 and IEC 82304 also refer to software life cycle processes. But what is a software life cycle?
Level of Concern and Documentation Level: What the FDA wants to achieve with it
1. Documentation Level: End of Level of Concern On June 14, 2023, the FDA released the guidance document Content of Premarket Submissions for Device Software Functions. This document replaces the guidance document introducing the Level of Concern and only distinguishes between two classes.
DetailsSoftware maintenance: How to avoid typical audit pitfalls
Software maintenance is the phase in which software is further developed, e.g., with the objective of According to the FDA, 79% of all bugs occur during software maintenance. Accordingly, some regulations address this topic.
DetailsGLP – Good Laboratory Practice
GLP (Good Laboratory Practice) defines requirements for a quality assurance system for non-clinical health and environmental safety tests. It also describes the organizational procedure and conditions under which laboratory tests are planned, carried out, and monitored. GLP also covers the record and reporting of. In this article, you can read which requirements medical device manufacturers…
Details