MEDISISS Response to FDA Article
The following letter was issued by our Vice President of Sales & Marketing, Ken Diebner, to all customers of MEDISISS. The subject concerns the impressive results we achieved during our most recent FDA inspection.
Dear MEDISISS Customer:
I am pleased to announce that MEDISISS has once again successfully completed an FDA inspection, known as a Quality System Inspection Technique, or QSIT. During such an inspection, all facets of our business operation are reviewable by the FDA. This type of inspection will involve any or all aspects of our quality systems and subsystems including, but not limited to, a review of our 510(k) clearances,Design Control Systems, Production & Process Controls including Cleaning, Packaging, Labeling & Sterilization, Equipment Controls, Raw Material Controls, Functionality & Inspection Controls, Corrective And Preventative Action Programs (CAPA’s), Non Conforming Reports, Internal Audits, Management Reviews, Customer Complaints etc.
In all aspects of the FDA’s review, MEDISISS achieved outstanding results. No "Observations" or "Deficiencies" (as referenced by the FDA’s Form 483) were noted. Having been deemed as fully compliant with the regulations and areas inspected, MEDISISS remains in good standing with the FDA.
As is evidenced by the results of this year’s inspection, our team remains committed to our Mission of providing the highest level of quality to ensure Patient Safety, Surgeon Satisfaction and FDA Compliance. When you use a MEDISISS device, you can do so with the highest level of confidence.
Thank you for your support.
Ken Diebner
Vice President, Sales & Marketing
MEDISISS
Redmond, OR 97756
866-866-7477
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