ISO Regulations & Compliance for Medical Devices
AT QTS, our team of professionals is dedicated and passionate about quality. This dedication combined with our strict adherence to medical device regulations and standards, enables QTS to deliver successful projects and improve the quality of life for others.
Certifications
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ISO 13485
Medical devices — Quality management systems — Requirements for regulatory purposes
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Compliant Standards
FDA CFR 21 Part 820
Quality System Regulation – Medical Devices
ISO 13485
Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971
Medical devices — Application of risk management to medical devices
ISO 14698
Cleanrooms and associated controlled environments — Biocontamination control (as of Jan 2009)
ISO 14644-1
Cleanrooms and associated controlled environments, Certified ISO Class 7 Cleanrooms
Licenses
State of Minnesota Board of Pharmacy Manufacturers License
View the QTS Procedural Guidelines
For more information regarding medical device ISO regulations and compliance, contact QTS.
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