Policies & Regulations
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2021.06.21
An Ingredient List for Your Medical Device?
FDA seeks feedback on medical device content labeling……
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2021.05.19
One Year After EU MDR Delay, Plenty of Barriers to Compliance Remain
Manufacturers continue to face a lack of clarity, high costs, and manual processes in order to comply with the new medical device regulation (EU MDR), according to a recent survey. These results come one year after the regulation’s postponement and a few weeks before the new validity date……
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2021.04.28
Chemical Compliance Requirements for EU MDR and IVDR
Is your medical device or diagnostic in compliance with this small, but essential, sub-section?……
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2021.04.21
What Are the Biggest Changes under EU MDR?
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements……
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2021.04.19
Companies, docs alarmed by proposed 510(k) rollback
Medical associations and device companies have largely come out against a Trump administration proposal to permanently exempt certain medical devices and software from the FDA 510(k) clearance process……
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2021.03.26
European regulators publish new Q&A on custom-made medical devices
The European Medical Device Coordination Group (MDCG) has issued a new document covering key questions and considerations regarding custom-made medical devices in the context of Medical Devices Regulation (MDR) compliance……
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2021.03.17
Why Risk-Based Thinking Is Essential in Medical Device Development
Many global regulatory requirements now include risk management, so medtech companies may need to revisit their quality system processes……
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2021.02.03
FDA says to limit mask decontamination to 4 cycles
Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations started claiming their decontamination systems could reprocess used filtering facepiece respirators (FFRs) such as N95s up to 20 times……
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2021.01.08
Traceability Requirements in EU MDR
Medical device manufacturers marketing products in the EU must ensure traceability between all stages of medical device development and post-market activities…….
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2020.11.26
Can Design Controls Accelerate Medical Innovation?
Response to the pandemic fast-tracked the pace of medtech innovation. In the future, can a human-centered iterative approach to design controls help maintain that momentum?……
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