Compliance Process

Change is the New Normal

By Huma.AI

…entitled, Managing CERs and PERS Programmatically to Meet EU Regulatory Requirements, four panelists discussed some of the common evidence hurdles manufacturers face in meeting the EU MDR and IVDR requirements…

…entitled, Managing CERs and PERS Programmatically to Meet EU Regulatory Requirements, four panelists discussed some of the common evidence hurdles manufacturers face in meeting the EU MDR and IVDR requirements…

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Irritation Tests

Biocompatibility in MedTech: Irritation Tests with Skin Models

By Dr. Christoph D. Lindner

To exclude hazards to users and patients, manufacturers must test their medical devices for biocompatibility. Biocompatibility tests are required in regulatory acts such as the Medical Device Regulation (MDR, Regulation…

To exclude hazards to users and patients, manufacturers must test their medical devices for biocompatibility. Biocompatibility tests are required in regulatory acts such as the Medical Device Regulation (MDR, Regulation…

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Risk Logic

In Search of Flawless Devices

By Huma.AI

Understanding EU MDR and IVDR: The goal of EU MDR and IVDR is to ensure safety by asking manufacturers to provide evidence that their products are safe (disclosing any risks),…

Understanding EU MDR and IVDR: The goal of EU MDR and IVDR is to ensure safety by asking manufacturers to provide evidence that their products are safe (disclosing any risks),…

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Lana Feng, Huma.AI

Artificial Intelligence Boosts New Era of Postmarket Intelligence

By Maria Fontanazza

…complying with the postmarket surveillance requirements of EU MDR and IVDR? Lana Feng, Ph.D.: [EU MDR and IVDR present] a new kind of active surveillance of product performance and safety….

…complying with the postmarket surveillance requirements of EU MDR and IVDR? Lana Feng, Ph.D.: [EU MDR and IVDR present] a new kind of active surveillance of product performance and safety….

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The Post-Market Gambit: After EU MDR and IVDR: A Systematic Compliance Framework for Driving MedTech Innovation

The Post-Market Gambit: After EU MDR and IVDR: A Systematic Compliance Framework for Driving MedTech Innovation

By Huma.AI

Based on extensive research and expert interviews, this 60-page ebook explores the challenges, costs, and opportunities that EU MDR and IVDR have created. Moreover, it offers a solution and vision…

Based on extensive research and expert interviews, this 60-page ebook explores the challenges, costs, and opportunities that EU MDR and IVDR have created. Moreover, it offers a solution and vision…

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Robert Dostert, DNV

The EU Medical Device Regulation (MDR): What Lessons Have We Learned?

By Robert Dostert

The Medical Device Regulation (EU) 2017/745 became the applicable EU law on May 26, 2021. After a four-year transition period, the first MDR approved devices are now hitting the market….

The Medical Device Regulation (EU) 2017/745 became the applicable EU law on May 26, 2021. After a four-year transition period, the first MDR approved devices are now hitting the market….

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magnifying glass

Legal and Normative Requirements: Ensuring the Functional Safety of Medical Devices

By Dr. Abtin Rad

…the European Union, the Medical Device Regulation (EU) 2017/745 (also known as MDR) defines the requirements for distributing medical devices within the EU. As far as functional safety is concerned,…

…the European Union, the Medical Device Regulation (EU) 2017/745 (also known as MDR) defines the requirements for distributing medical devices within the EU. As far as functional safety is concerned,…

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Structural Analysis

Addressing ‘Equivocal’ Toxicological Assessment Results with Risk Mitigation Strategies

By Kim Ehman, Ph.D., Sandi Schaible, Sherry Parker, Ph.D.

…the EU under the Medical Device Regulation (MDR), the expectation is that chemical characterization is done in compliance with ISO 10993-18. The revised ISO standard would be considered “state-of-the-art,” as…

…the EU under the Medical Device Regulation (MDR), the expectation is that chemical characterization is done in compliance with ISO 10993-18. The revised ISO standard would be considered “state-of-the-art,” as…

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