Sean Fenske, Editor-in-Chief09.15.20
Testing has always been a critical process within the medical device development pathway. Similarly, the complexity of the protocols has remained substantial as well. As such, outsourcing these necessary procedures has been a successful option for medical device manufacturers, both large and small. Ensuring an in-house team is aware of the latest ISO standards and regulatory demands can be challenging. As such, working with experts who focus exclusively on life sciences testing is often preferred.
Recently, however, keeping up with the changes happening across the industry, from ISO revisions to new EU regulations to updated FDA guidance, has perhaps never been more difficult. The requirements for testing have ratcheted up to an even greater level (or soon will be), so in order to ensure a device launch remains on time and doesn’t encounter resistance from a regulatory authority, manufacturers are leaning on their testing solution partners even harder.
As such, ODT reached out to a variety of testing experts to get their assessment of the landscape and offer advice to orthopedic device manufacturers on factors they should keep top of mind. Whethe
Recently, however, keeping up with the changes happening across the industry, from ISO revisions to new EU regulations to updated FDA guidance, has perhaps never been more difficult. The requirements for testing have ratcheted up to an even greater level (or soon will be), so in order to ensure a device launch remains on time and doesn’t encounter resistance from a regulatory authority, manufacturers are leaning on their testing solution partners even harder.
As such, ODT reached out to a variety of testing experts to get their assessment of the landscape and offer advice to orthopedic device manufacturers on factors they should keep top of mind. Whethe
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