Device manufacturers that haven't begun conforming to various ongoing international regulatory changes are behind the 8-ball and risk noncompliance, industry insider Kim Trautman says.
Medical device manufacturers that haven't begun conforming to various ongoing international regulatory changes are already behind the 8-ball and are at risk of falling out of compliance when deadlines arrive, a longtime industry expert says.
"Not only does industry have the new ISO 13485 hitting it, but industry also has MDSAP hitting it for, at a minimum, product entry into Canada. Then there are all...
The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.
A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
