Resource Centre
Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.
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ISO/IEC 17025:2017 includes many changes. Three points to keep in mind: more options, involvement of risk, updates in current technology.
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Why design control is required for medical devices and is superfluous in the consumer goods design with advantages and disadvantages.
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GDPR is designed to enhance the privacy and security of data subjects. Medical devices and GDPR cross paths in many areas.
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Design control shouldn’t inhibit creativity; it should enable it by providing a safety net in the form of a system to fall back on.
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StarFish Medical videos help viewers learn medical device design, development and manufacture insights and tips from the people at StarFish.
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RoHS and REACH compliance is required to sell equipment or consumer parts with hazardous materials in EU, China, Korea, United States and Canada.
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How to handle recent medical product development regulatory changes under the 21st Century Cures Act and device exemption list.
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Start early to avoid surprises when preparing for MDR 2017/745. The new EU medical device regulations will come into full force in Q2 2020.
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Tips to manage competence and training, keep up to date and ensure personnel are trained and competent to perform their duties.
