I’m willing to bet you’re here because of a specific incident. Maybe it was during a batch record review, you saw a signature next to a step that you know, for a fact, was not performed correctly.
If you work in the medical device industry, you already know that medical device risk management is a part of the job from the very beginning. Whether you're bringing a new product to market or continuing with an existing one, the way you approach ri...
Getting through an ISO audit is one of the most important defining moments for any life sciences company. Whether you’re manufacturing pharmaceuticals, developing medical devices, or working in biotech, these audits are how regulators and customers c...