A discussion with Geoff Wood about the advantages offered by having a pre-assessment before a Stage 1 and 2 Initial Audit.
The report also found that medical device companies are taking “huge gambles” in the area of risk management.
A guide to what to expect during your certification audit and how to prepare.
Overall, MDSAP will reduce the time and resources required for audits and inspections, and aid in international trade.
Don’t overlook this critical practice.
An FDA inspection should never be confused with a notified body audit.
FDA appreciates nothing more than documented evidence of compliance.
Storing gasoline next to orthopedic trays and instrument trays just isn’t a good idea.
Risk Management is the single most important topic impacting the medical device industry today.
Payer organizations face a host of issues in the conversion to ICD-10.