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Cybersecurity in Medical Devices: FDA Final Guidance Breakdown

Cybersecurity in Medical Devices: FDA Final Guidance Breakdown

by Jonathan Amaya-Hodges | Oct 3, 2023 | Blog

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Cybersecurity in Medical Devices: FDA Final Guidance Breakdown Last week, the FDA issued the final guidance “Cybersecurity in Medical Devices: Quality...
FDA Draft Guidance on Prescription Drug-Use-Related Software

FDA Draft Guidance on Prescription Drug-Use-Related Software

by Jonathan Amaya-Hodges | Sep 22, 2023 | Blog

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Newest FDA Draft Guidance on Prescription Drug-Use-Related Software Will Be a Tool on Your Journey to Filing Success The FDA has shared a new draft...
FDA Final Guidance on Human Factors for Combination Products

FDA Final Guidance on Human Factors for Combination Products

by Jonathan Amaya-Hodges | Sep 12, 2023 | Blog

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Have you reviewed the FDA’s final guidance on human factors for combination products?   Our team of CP experts have made a cheat sheet of key points...
Are You Managing Your Combination Product Supplier Relationships Well Enough?

Are You Managing Your Combination Product Supplier Relationships Well Enough?

by Jonathan Amaya-Hodges | Jun 14, 2023 | Blog

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Are You Managing Your Combination Product Supplier Relationships Well Enough? Unless you are a company that “does it all” (and at the time of...
Seven Common Misconceptions About Implementing A Combination Product Quality Management System

Seven Common Misconceptions About Implementing A Combination Product Quality Management System

by Jonathan Amaya-Hodges | May 4, 2023 | Blog

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Seven Common Misconceptions About Implementing A Combination Product Quality Management System While a Combination Product is made up of a drug...
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Industry News

  • Cybersecurity guidance for any software connected to a combination productCybersecurity in Medical Devices: FDA Final Guidance Breakdown
    October 3, 2023
  • Helpful Links for Software Connected Combination Products
    September 26, 2023
  • FDA Draft Guidance on Prescription Drug-Use-Related Software
    September 22, 2023

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