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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This blog explores key highlights of the Chemical Analysis for Biocompatibility Assessment of Medical Devices draft guidance, focusing on its scope, testing methodologies, and recommendations for reporting. In September 2024, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Chemical Analysis for Biocompatibility Assessment of Medical Devices.
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Medical Device Commercialization Resolutions include Improved communications, aligning goals, using new tools, going paperless
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2024 Medtech Entrepreneur Webinars feature both standard expertise webinars and livecast recordings from Playbook events in Vancouver, Canada and Newport Beach, California.
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2024 Top Medical Device Blogs written in 2024 and the 10 most read evergreen blogs during 2024 include three new authors, two group blogs and five articles from blogging veterans.
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2024 Top Medical Device Videos features a round up of most viewed medical device videos from StarFish Medical includes a mix of new videos released in 2024 along with evergreen videos sharing medical device expertise.
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A combination product is a product which comprises of two or more items which are covered by different regulations, for example a pharmaceutical and a medical device. As they are covered by two different regulatory structures, then more care needs to be taken when determining the regulatory strategy as it will be more complex.
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This blog discusses the combination product regulation basics and explains how these types of products are regulated in the US and EU.
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Overview of tools for Root Cause Analysis is an important tool in medical device development and manufacturing.
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Predetermined Change Control Plans (PCCPs) Draft Guidance with Implications for Medical Device Manufacturers and regulatory framework
