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Tag: Medical Device Verification Validation

7 New Developments That Impact Medical Devices

We recently asked our engineering and QA/RA leaders which new developments are likely to impact medical devices in the near- and long-term future.Their responses...

ALARP to AFAP, the MDR and ISO 14971:2019+A11:2021

The risk management approachALARP (As Low As Reasonably Practicable) to AFAP (As Far As Possible) and medical device risk management has always been a...

Cancer detection technologies on microfluidic chips

When you hear the word cancer, it conjures up sad feelings. Most patients think that if they have it, they have less chance to...

FDA Publishes Draft Ethical Consideration Guidance to Protect Children Participants in Clinical Trials of Medical Products

On September 23, 2022, the Food and Drug Administration (FDA) published a draft guidance aimed to protect children who participate in clinical trials, titled Ethical...

Medtronic Completes Acquisition of Cardiac Mapping Company Affera

Medtronic recently announced that its acquisition of Affera, Inc. has been completed. The acquisition was previously announced to be for $925 million with a...

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