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  When to implement your Quality Management System

  Advice, implications and examples for best time to implement a medical device Quality Management System in US, Canada and Europe.

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  Meeting with the FDA

  Meeting with the FDA can put almost everybody in the company in panic mode. Benefits of FDA meetings and what to expect.

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  Do’s and Don’ts of Medical Device Labeling

  Medical device labeling includes all information provided with the device. Article identifies jurisdictions and associated “do’s and don’ts”.

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  Ready for FDA UDI compliance

  UDI compliance: What does that mean for your products and your company? Link to additional information about UDIs on the FDA website.

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  Advice from a former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations

  Interview with Larry Spears, Former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations on prep for regulatory submissions.

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  StarFish Analysis: Health Canada online publication of Regulatory Decision Summaries (RDS)

  Health Canada has announced online publication of Regulatory Decision Summaries (RDS) and a list of decisions under review.

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  11 Things to avoid to achieve RoHS compliance

  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 devices – regulatory and technical implications

  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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  Six tips for medical device CFD simulations

  Medical device CFD simulations allow you to generate images and videos with little effort to predict and optimize fluid and thermal paths.

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