Mario Klessascheck

Berater für EMV und elektr. Sicherheit


System architecture (not only) for medical devices

The system architecture describes the components of a (medical) device and how these components interact with each other via interfaces. For standalone software, the system architecture and software architecture coincide. 1. Documentation of the system architecture a) Notation language The documentation should reveal the individual components and their interaction. It has been proven that using…

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Systems and procedure packs

The European legislation defines systems and procedure packs and distinguishes between different configurations. The regulatory requirements placed on the manufacturer are heavily dependent on these configurations. This article will explain to you what legislators understand by systems and procedure packs, what the most important legal requirements are for manufacturers, and what common mistakes you should avoid. 1.…

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Harmonized standards: Evidence for medical device manufacturers

Most manufacturers use harmonized standards to demonstrate the conformity of their devices with the general safety and performance requirements. This also applies to medical device manufacturers, for example. 1. Standards and harmonized standards a) Definitions and more EU Regulation 1025/2012 defines the term harmonized standard. Standards are documents written by national or international standardization commissions…

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EU Battery Regulation: What medical device manufacturers need to know

The EU plans to replace the existing Directive 2006/66/EC with the new EU Regulation on batteries and waste batteries (“Battery Regulation”). This article clarifies, 1. Background a) Objective With the Battery Regulation, the EU aims to modernize the legal framework for batteries. The regulation is a response to calls for a comprehensive revision and expansion…

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