Refine by
Iso 13485 Certification Articles & Analysis
5 articles found
Choosing the wrong supplier for medical drainage bags can expose your facility to safety risks, compliance violations, and costly downtime. Procurement professionals are expected to evaluate products quickly and confidently, but not all warning signs are obvious upfront. This guide breaks down five key red flags to watch for so you can make smarter, safer purchasing decisions and ...
These tests can take several forms, such as: Bubble tests Dye penetration tests Immersion tests Microbial challenge tests Trace gas leak tests If you’re in the market for a packaging manufacturer for medical devices, search for a company with a track record of receiving FDA approval for its packaging systems. ISO Standards The International Organization for ...
While this guideline more clearly defines what requires FDA Certification, one has to wonder what the FDA’s plans are for enforcement. ...
Ambient Clinical Analytics has achieved FDA Class II Clearance, CE Marking, and ISO 13485:2016 Certification on the AWARE™ and AWARE Sepsis DART™ platform. ...
Coming Soon: CAPA Guidance Changes The FDA has already announced its intent to transition to ISO 13485:2016, with a proposed rule to replace the current Quality Systems Regulation (QSR) set to come out in fall 2019. In addition, the FDA plans to use Medical Device Single Audit Program (MDSAP) audits—where scoring is based on ISO ...
ByEtQ, LLC