How to choose a consultant for ISO 13485 implementation

If your company has decided to implement the ISO 13485 standard, you might be considering bringing in a consultant to assist with the implementation process. The wise selection of an ISO 13485 consultant is one solution that will greatly increase your chance of success and decrease your timeline in accomplishing accreditation. …

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ISO 13485 structure and requirements

Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 requirements and structure. The standard includes …

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Design and development validation and verification according to ISO 13485

Producing any part of a product includes validation and verification in its design and development. ISO 13485 requirements are a great way to start, since it’s targeted specifically to medical device manufacturing. According to the American Society for Quality, the definition of validation in a quality environment is the act …

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