MedTech Intelligence: Better Representing Our Business
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Tag Archives: medical device summit
Audit Your Own Area, Receive a Warning Letter!
Do not be the organization that fails to perform the audits and attempts to correct the issue after FDA arrives.
The United States of America v. Medtronic., a corporation, and S. Omar Ishrak and Thomas M. Teft, individuals
There is no such thing as minimum or maximum compliance—there is just compliance.
Rework of Nonconforming Product Must Be Documented
As finished devices become more complex and the cost of assembly operations increase significantly, it is imperative that device establishments have the ability to successfully rework nonconforming product.
Chief Jailable Officers Indicted for Adulteration and Misbranding of Medical Devices
If the FDA fails to clear or approve a medical device or an expanded indication for use, “No means No!”
If the FDA fails to clear or approve a medical device or an expanded indication for use, “No means No!”
You Gotta Validate Design Changes!
Even what may appear as simple design changes need to be reviewed for the need to repeat design validation.
Purchasing Controls is not Rocket Science!
A well-balanced purchasing controls program encompasses many tools, but in an effort to meet the requirements delineated within §820.40, the FDA expects establishments to have certain elements in place.
A well-balanced purchasing controls program encompasses many tools, but in an effort to meet the requirements delineated within §820.40, the FDA expects establishments to have certain elements in place.
Imagine There’s No Receiving Inspection – It’s Easy If You Try
FDA has given device establishments a gift in regard to the vagueness of the RI requirement. It is up to each device establishment to decide how much RI is required. However, at the end of the day the approach for RI must be defendable during an agency inspection, and when in doubt, the approach to RI should be risk-based.
Not Collecting DHRs for Nine Months is an Incredible Feat for any Device Manufacturer
Device History Records are not optional. So do not be that Chief Jailable Officer that has to sit across from that FDA investigator without the documented evidence of compliance needed to defend your establishment’s QMS (or lack of it).
Failing to Evaluate Non-Conformances is Bad Medicine
Remember these takeaways: When nonconforming product is identified, quickly bag it and tag it. Make sure the disposition process is well documented, including evidence of an investigation to support it; and use a locked quarantine.
