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Author Archive | Peter Sebelius

The perfect project process for medical device product development

Having the perfect project process can be key in developing products in as short time as possible and as low cost as possible. It can allow you to exercise control over projects, especially in multi – project environment. A well-recognized project process will facilitate introduction of new employees or new project team members, but not […]

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The secret requirements list

You perhaps believe that you can read which requirements apply in the laws and standards for medical device manufacturers like ISO 13485 or 93/42/EEC, and to an extent that’s true. But to an increasing extent I’m encountering requirements that notified bodies and authorities have set and which aren’t documented anywhere. These requirements are much more […]

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FMEA and Risk management according to ISO 14971

Risk management vs FMEA Risk management for medical devices is a comprehensive approach, including requirements for planning the development of a device, to the requirements for a device that is no longer on the market. Even though the standard in application of risk management to medical devices has been around for almost 15 years, there […]

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