MDSAP: Medical Device Single Audit Program

MDSAP: Medical Device Single Audit Program

The Medical Device Single Audit Program (MDSAP) provides medical device manufacturers an option for a single audit that satisfy the regulatory requirements of five participating countries (Australia, Brazil, Canada, Japan, USA), and allows medical device companies to...
Laboratory Audits: Overview, Guide, and Tips

Laboratory Audits: Overview, Guide, and Tips

Regulatory bodies such as the ISO and the FDA frequently evaluate laboratory operations to check compliance. Because laboratories guarantee quality in medical device and pharmaceutical companies’ operations, any non-conformance in the laboratory can mean...
Remote Auditing Best Practices in Life Sciences

Remote Auditing Best Practices in Life Sciences

Remote audits offer an indispensable tool for improving and verifying medical device, pharmaceutical, and other life science organization’s compliance with the specific standards. Especially amongst the current travel restrictions due to the pandemic. Although,...