Regulations

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Get Ready for FDA Accepted Predetermined Change Control Plans!

Written by Mark Swanson, Partner On April 3rd, the FDA issued the draft guidance titled, “Marketing Submission Recommendations for a...

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Auditing, the Often-Thankless Task

by Steve Gompertz, QRx Partners Performing audits is great way to increase your understanding of quality management system requirements...

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The Long and Winding Road - Shortcuts to FDA Market Authorization

by Mark Swanson and Steve Gompertz, QRx Partners While most medical devices are required to follow the 510(k) and PMA pathways, the FDA...

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Likely EU MDR Postponement: EU Finally Sees the Light

by Steve Gompertz, QRx Partners If you’re involved in the medical device industry, you’ve likely heard recently that the EU is...