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Regulatory Compliance

Our manufacturing facilities are compliant with the requirements of the FDA’s Quality System Regulation (QSR) and Current Good Manufacturing Practice (CGMP), and our QMS is certified to the international standards ISO13485:2003.

Our product development and manufacturing processes are regularly audited under the direction of internal auditing team as part of our ongoing commitment to continuous quality improvement.

Additionally, SGS also audits our quality system and facilities on a regular basis for maintenance of this registration. You can count on our quality with confidence. Our quality procedures assure our clients that our services meet their standards of excellence for medical product design, development, and manufacturing controls.

For companies seeking entry to the US & European markets, we are also qualified to provide the technical product documentation needed to meet FDA & CE requirements.


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