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.

For more information regarding medical device ISO regulations and compliance, contact us.

Certifications 

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ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes

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

JPAL
JPAL MHLW Ministerial Ordinance No. 169, 2004

Japanese Manufacturing Certification
Certified Foreign Medical Device Manufacturer, pursuant to Article 13-3 of the

Pharmaceutical Affairs Act.

Licenses
State of Minnesota Board of Pharmacy Manufacturers License

Contact QTS for more information on Quality System Impacts of Unique Device Identification (UDI).

View the QTS Procedural Guidelines