New Developments in 2014 Bring Challenges for Designers

Fri, 01/31/2014 - 1:53pm
Mike Brousseasu, Manager — Safety Group, and Joe Langton, Business Service Line Leader — Chemical, Intertek

Q: What’s in store for the medical device sector in 2014?

Joe LangtonIn the coming year, medical device manufacturers will need to focus on getting their products compliant, available, and possibly re-designed to keep up with the ever-changing standards associated with the medical device industry.

The Affordable Care Act has shifted the healthcare system from one that focuses on acute hospital care to solutions in the home. As a result, medical device manufacturers must focus on designing products specific for home or non-hospital use while ensuring the devices comply with more extensive in-home standards like the third edition of IEC 60601-1-11.

If the product will be sold in the European Union, it must also comply with the RoHS 2 directive by the July 22, 2014 deadline, which restricts the use of six substances and now requires a technical file. This new change can require considerably more work for manufacturers, suppliers, and importers when documenting and monitoring medical devices.

In addition, medical devices are now beginning to incorporate wireless communication and charging capabilities to bring functionality and ease of use to a new level.

Given these new developments, there are many considerations and regulatory requirements involved in selecting, implementing, and bringing a medical device to market that need to be top-of-mind in 2014.


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