Tag: EU Medical Device Regulation

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The EU MDR Deadline and What Happens Now

Medical device companies doing business in the European Union (EU) may have ...

EU Medical Device Regulation, Medical Devices, Product Compliance

Why EU MDR Compliance Is Important for Global Manufacturers

Understand EU MDR compliance to avoid lost sales and product recalls. Ensur ...

EU Medical Device Regulation, Product Compliance

The Regulatory Landscape for Medical Devices

Due to their impact on human life, medical devices are highly regulated. No ...

EU Medical Device Regulation, Medical Devices, Product Compliance, Supply Chain Sustainability

Increased Personal Protective Equipment Production: What About Compliance?

Since the COVID-19 pandemic hit, there has been an unprecedented demand for ...

EU Medical Device Regulation, Product Compliance, Supply Chain Sustainability

Contact lenses, at the intersection of REACH and EU MDR.

Contact Lens Solution Caught In Between REACH Regulation, EU Medical Device Regulation Conflicts

Get insights on REACH and EU MDR discussions and their importance for the f ...

EU Medical Device Regulation, Product Compliance, REACH

A stethoscope and watch, representing the EU MDR extension.

Changes to EU MDR See Deadline Extended 12 Months

Discover how the EU MDR deadline extension supports medical device companie ...

EU Medical Device Regulation, Product Compliance

5 Steps to Transforming Your Supply Chain to Build Emergency Medical Equipment

Manufacturers are being asked to begin producing emergency medical equipmen ...

Corporate, EU Medical Device Regulation, Product Compliance

How Brexit Will Impact the EU Medical Device Regulation

After the UK formally left the European Union (EU) on January 31, 2020, a n ...

EU Medical Device Regulation, REACH, RoHS, SCIP, Trade Classification & Origin

Proposed Update to EU MDR Deadline

The COVID-19 (coronavirus) outbreak has put a halt to many aspects of every ...

EU Medical Device Regulation, Product Compliance

A room of surgeons using equipment regulated under the EU MDR.

EU MDR: What to Do if Your Company Is Unable to Comply by the Deadline

Will your products meet the EU MDR standards? Learn about the compliance ch ...

EU Medical Device Regulation, Medical Devices, Product Compliance, RoHS

Banner featuring an Assent product compliance expert.

Ask the Experts: The Difference Between REACH Restricted Substances & Candidate Lists

Our regulatory subject matter experts help a range of stakeholders solve co ...

EU Medical Device Regulation, Human Trafficking & Slavery, Medical Devices, Product Compliance, REACH, RoHS

Banner featuring an Assent product compliance expert.

Ask the Experts: January 10 Edition

Gain insights from our compiled content, webinars, and events aimed at educ ...

EU Medical Device Regulation, Medical Devices, REACH, RoHS, SCIP

Medical professionals discussing the EU Medical Device Regulation (MDR).

What the Two-Year EUDAMED Delay Means for Medical Device Companies

The European Commission recently announced it would delay the launch of the ...

EU Medical Device Regulation

The Scope of the EU Medical Device Regulation

The European Union (EU) Medical Device Regulation (MDR) is due to take full ...

EU Medical Device Regulation, Medical Devices

Understanding Section 10.4.1 of the EU MDR

After a three-year transition period, the European Union (EU) Medical Devic ...

EU Medical Device Regulation, Medical Devices

Navigating the Compliance Landscape: Medical Devices

This eBook offers valuable information on the product compliance, corporate ...

EU Medical Device Regulation, Medical Devices

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