Barely a week after the FDA issued its final guidance on wireless devices, some already see a small-business opportunity in trying to help device companies navigate the new rules.
Global Technology Resources, a Colorado IT operation focused on areas including Big Data, mobile software and system security, said it will partner with healthcare/medical device consultancy Integra Systems in Nevada to help device companies interpret the new requirements and adjust their regulatory submission strategies accordingly.
Surely, others will follow suit, if they haven't already. But the partnership, among the first announced since the FDA issued its new guidance in mid-August, speaks to device companies' ongoing struggle to negotiate the regulatory process as it becomes more technologically complex.
Both companies say they'll hit all the sweet spots that the new guidance affects, including electromagnetic compatibility testing, wireless performance and security, and assessment of the reliability of wireless devices and medical equipment in their capacity to support critical functions for patients.
The new rules, issued Aug. 13, are designed, in part, to make devicemakers show how they will keep their products from getting hacked. But there are also plenty of guidelines designed to make sure devices run successfully in the presence of other devices. Regulators also want to ensure regular software updates to maintain patent safety, and guarantee that electromagnetic emissions from wireless devices remain at safe levels.
The FDA's guidance is very detailed, but regulators included a glossary of terms to help device developers plod through the detailed new instructions. That alone serves as a sign that some outside interpretation couldn't hurt.
- read the release
- here's the FDA's guidance