regulatory

Posts tagged with “regulatory”

Vincent Crabtree

7 Tips for Efficient Medical Device Submissions to IEC 60601 Edition 3

We have been doing quite a lot of work for clients submitting their electrical devices for IEC 60601 Edition 3 electrical safety testing.  For those unfamiliar, most users of medical devices would agree that mandatory electrical safety testing is a good thing before devices are allowed on the market.  Now, 60601 Edition 3 takes this […]

Vesna Janic

FDA Recognition Standard List Number 30 for Medical Devices

On January 15, 2013 the Food and Drug Administration (FDA) published an updated list of standards the Agency recognizes for use in premarket reviews of medical devices. This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 030” will assist manufacturers who choose to declare conformity with consensus standards.

Boyd Allin

Design Reviews in Medical Device Development

During the development of medical and consumer electronic devices there are scheduled design reviews held in order to comply with IEC 60601 and to ensure the best product is realized. These reviews are invaluable; however, a few common pitfalls are worth identification.   One tendency is to narrow the audience to a myopic group of […]

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