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 […]
Audits and inspections are a regular occurrence in Life Science companies that operate under Health Canada, US FDA, EU MDD, or any other regulations and/or standards. The experience can be very positive or very stressful depending on how well prepared you are. In preparation for an audit/inspection, both parties need to be clear on the […]
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.
Internal Audits are vital in medical device development, but the results of an internal audit are not always the easiest to hear. Depending on the level of depth that an internal audit goes into, the results and feedback can seem nit-picky and extremely negative. If this resonates with you, and you too fear the letters […]
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 […]
Like Wile E. Coyote’s persistent attempts at catching the Roadrunner, sometimes it takes multiple attempts to get a product through EMC testing. Why? And what can we do to increase the likelihood of passing on the first or second iteration? Electromagnetic Interference (EMI) is unwanted effects in a medical device due to electromagnetic energy present […]
On Oct 18, 2012., the FDA released a new draft guidance entitled – eCopy Program for Medical Device Submissions.The intent of this guidance is to improve the efficiency of the review of an electronic version rather than relying solely on the paper version of the submission. An electronic copy (eCopy) is defined as an exact duplicate […]