Our free Starter-Kit provides you with an overview of the governing laws and regulations and guidance through a typical medical device approval process.
The Johner Institute's newsletter keeps you updated on changes affecting the Medical Device and IVD industry.
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Our cutting-edge artificial intelligence technology scans, analyzes, and interprets vast amounts of regulatory data, allowing us to provide you with the most accurate and up-to-date information relevant to your product portfolio of medical devices.
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We navigate you safely through the jungle of laws and regulations and ensure that you get global market access for your medical device.
We support getting your QMS ISO 13485:2016 and 21 CFR 820 compliant or establishing a QMS from scratch with our eQMS solution.
We help you create an IEC 62366-1 and FDA-compliant usability file and conduct formative and summative evaluations to achieve approval quickly and cost-effectively.
Demonstrate product compliance with clinical trials, usability testing, and electrical and biological safety testing.