The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.
Pharma and Tech Working in Sync to Enhance Health.
This online series of workshops will arm you with the information you need to overcome challenges and achieve compliance with EU MDR.
A guide to the steps companies can take to evaluate their device developer’s HFE process.
The device should be carefully matched to end users, rather than be an afterthought.
Manufacturers finally have some clarity on which CGMP requirements apply when producing a combination product.
Several provisions are aimed at accelerating device innovation and access to medical products.
FDA releases achievements of its Combination Product Review Program, along with next steps for the near term.
Some key factors that companies should not overlook when developing drug-device products.
Some insights on integrating stability testing requirements into a device organization’s plan to make combination products.