Longtime industry expert Connie Hoy says medtech companies that sign up for an audit through the Medical Device Single Audit Program will have a leg-up if they prepare beforehand by reading the MDSAP Companion Document. The doc can also be used to train workers on what an MDSAP auditor will be looking at and asking for.

Four enforcement letters were sent by the US FDA to makers of adulterated COVID-19 serology tests.

Roughly six months after releasing an updated version of its risk management standard ISO 14971, the International Organization for Standardization (ISO) has published companion document Technical Report 24971.

The warning letters sent to Medakit Ltd., antibodiescheck.com and Sonrisa Family Dental are the first enforcement missives sent by the US agency related to false or misleading marketing for the serological tests, which can detect if a person is infected with the SARS-CoV-2 virus, or had the disease in the past.

Manufacturers of devices granted emergency use authorization (EUA) status during the COVID-19 crisis are fully responsible for filing any adverse events about the products to the FDA, the US agency says on a new FAQ page.

The FDA instructed a device maker to hire a consultant to audit its “manufacturing and quality assurance systems” in the only device-related warning letter released by the US agency this week.