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Life Sciences Blog

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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Usability%20Testing%20and%20MDR%20Managing%20Risk%20with%20the%20Human%20Factor.jpg

Usability Testing and MDR: Managing Risk with the Human Factor

Under the EU Medical Device Regulation (MDR), usability is no longer a ‘nice-to-have’—it’s a core component of your risk management strategy. The MDR places...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/In-Silico%20Testing%20&%20MDR%20Smarter%20Evidence%2c%20Not%20Optional%20Evidence.jpg

In-Silico Testing & MDR: Smarter Evidence, Not Optional Evidence

In-silico testing — using computational modeling and simulation techniques — has rapidly become an important method for supporting compliance with the EU...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/MDR%20&%20Cybersecurity%20What%20Your%20Technical%20File%20Needs%20to%20Prove.jpg

MDR & Cybersecurity: What Your Technical File Needs to Prove

Cybersecurity has become a fundamental requirement under the Medical Device Regulation (MDR). Medical device manufacturers must now actively demonstrate...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Post-Market%20Surveillance%20%28PMS%29%20and%20Post-Market%20Clinical%20Follow-Up%20%28PMCF%29%20under%20the%20MDR%20ensuring%20safety%20and%20performance.jpg

Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) under the MDR: Ensuring safety and performance

With the introduction of the Medical Device Regulation (MDR), the requirements for placing medical devices on the market have significantly increased....
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Imported_Blog_Media/Declaration-of-Equivalence-for-Medical-Devices-under-the-MDR-1-1.jpg

Declaration of Equivalence for Medical Devices under the MDR

With the Medical Device Regulation (MDR 2017/745) being more stringent than the previous European Medical Device Directive (MDD) or the Active...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Blog%20-%20MDR%20Certification%20for%20Legacy%20Devices%20Integrating%20Clinical%20Evidence%20for%20Compliance%20-%20QbD%20Group.jpg

MDR Certification for Legacy Devices: Integrating Clinical Evidence for Compliance

Medical Devices CE certified under the European Medical Device Directive (MDD) or the Active Implantable Medical Devices Directive (AIMDD), are frequently...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Imported_Blog_Media/Anticipate-the-Notified-Body-Rush-Ensure-Timely-MDRIVDR-Compliance-1-1.png

Anticipate the Notified Body Rush: Ensure Timely MDR Compliance

The rules outlined in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are crucial in ensuring patient safety and granting...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Imported_Blog_Media/CE-Approval-for-Medical-Devices-under-MDR-key-requirements-for-your-device-class-1.png

CE approval for Medical Devices under MDR: key requirements for your device class

Conformity assessments for CE approval As indicated on the website of the European Commission, a medical device can only be placed on the EU...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Imported_Blog_Media/How-to-Plan-MDR-Compliance-for-Your-Medical-Device-1.jpg

MDR transition: how to plan MDR compliance for your Medical Device?

In June 2022, concerns were expressed that severe challenges related to the implementation of Regulation (EU) 2017/745 on medical devices (MDR) would...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Imported_Blog_Media/MDR-Annex-XVI-products-with-non-medical-purpose-%E2%80%94-Compliance-and-Common-Specifications-CS-QbD-Group-1.jpg

MDR Annex XVI: products with non-medical purpose — Compliance and Common Specifications (CS) 

Annex XVI of the MDR EU 2017/745 lists products (6 categories) without an intended medical purpose that now fall under the MDR. Manufacturers of these...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Imported_Blog_Media/European-Parliament-adopts-proposed-amendment-to-MDR-to-extend-transitional-deadlines-for-certain-Medical-Devices--1.jpg

The European Parliament adopts proposed amendment to Medical Devices Regulation 2017/745 (MDR) to extend transitional deadlines for legacy Medical Devices 

The European Parliament has adopted the proposal to extend the transitional period for legacy devices (i.e. those covered by a certificate or...
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PRRC under MDR and IVDR: meaning, requirements, and responsibilities

PRRC: meaning of this new role under MDR and IVDR The Person Responsible for Regulatory Compliance or ‘PRRC’ is a mandatory role introduced by the ...
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