The Top Trend for Medical Devices in 2021? Putting Quality First
Moving too quickly in the product development process can lead to mistakes.
Tag Archives: EU MDR
EU MDR Approval: Performing the Literature Search
Under the new regulation, medtech manufacturers can no longer defend their claims with limited clinical data; the depth, breadth and scrutiny on clinical data is much more rigorous.
EU MDR Strategy: How to Effectively Deploy Consultant Partnerships
Achieving EU MDR compliance is considerably challenging for many businesses, which is why they must be discerning when it comes to selecting suitable partners.
Cybersecurity, COVID-19 and EU MDR Hot Topics of the 2020 MedTech Summer
Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.
Managing Testing Strategies Under the EU MDR
Companies can improve their chances for a successful transition by leveraging their knowledge of their medical devices and understanding what each device’s categorization under the MDR means to its testing strategy.
EU MDR 101: Preparing Technical Documentation
Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.
Playing by the Rules: A Lever for Doing Better Business?
Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.
Postmarket Surveillance: The Urgent Need for a Holistic Approach
Simplifying the PMS process globally from end to end, can help medtech companies realize significant improvements across the board while keeping operating costs under control.
Economic Operators: New Responsibilities Shake Up MedTech
One ill-prepared EO can impact the entire supply chain.
GS1 Updates Global Model Number Identifier For Use as a Basic UDI-DI to Meet EU MDR Requirements
A recap of a recent effort involving a small group of AIDC experts in devising a data integrity scheme suitable for protecting a new device identifier used in modern healthcare applications against mis-keying. It presents the group’s undertakings in researching solutions to ensure identifier integrity, the challenges encountered, and how a more complete understanding of the constraints of the intended application led to a departure from the initial design and resulted in the elegant solution that exists today.
