We employ a robust Quality Management System and a system for electronic storage and change tracking of records and provide DMR and DHR traceability. We are responsive and intentional in regards to issues affecting the medical device industry such as RoHS, REACH and conflict minerals.
When you partner with QTS, we guarantee you will have a QCALIBER experience from start to finish.
ISO 13485 Certified, FDA Registered, ISO 11607 Compliant, J-PMDA Compliant
Certifications
ISO 13485 Certificate – Medical devices – Quality management systems – Requirements for regulatory purposes.
MedAccred Certificate – Sterile Device Packaging – Assembly and Closure/Sealing of Packaging Systems.
Compliant Standards
FDA CFR 21 Part 820 – Quality System Regulation – Medical Devices
ISO 13485 – Medical devices – Quality management systems – Requirements for regulatory purposes
ISO 11607-1 – Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging
ISO 11607-2 – Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
ISO 14971 – Medical devices – Application of risk management to medical devices
ISO 14698 – Cleanrooms and associated controlled environments – Biocontamination control
ISO 14644-1 – Cleanrooms and associated controlled environments, Certified ISO Class 7 Cleanrooms
J-PMDA – J-PMDA MHLW Ministerial Ordinance No. 169
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
