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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Top 2015 medical device blogs written by StarFish Medical expert employees sharing their knowledge, tips, and tools.
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Expedited Access Pathway (EAP) is promising for timely approval and access to devices for life-threatening or irreversibly debilitating conditions.
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Recent report on policies and initiatives claims the FDA device arm (CDRH) medical device approval process is much faster than five years ago.
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Outsource Selection using a checklist manifesto for medical device development consideration and comparison of service providers.
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Interview with Larry Spears, Former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations on prep for regulatory submissions.
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Health Canada has announced online publication of Regulatory Decision Summaries (RDS) and a list of decisions under review.
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RoHS is still a hot topic. Background on RoHS compliance with 11 parts and processes to watch out for during the design stage.
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Digital Health & medical device regulatory and technical implications: HIPAA, Mobile Medical App (MMA), Medical Device Data System (MDDS), and app stores.
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FDA medical device accessory guidance lessens regulatory burden, permitting low risk devices to market faster and cheaper.
