Regulatory and Compliance
With 35+ years of medical device experience, we have developed a thorough understanding of the complex regulatory environment. Every product is manufactured to exact specification, in full compliance with FDA guidelines, at one of our ISO-certified facilities.
- ISO 13485:2003 Certified
- FDA Registered and compliant with the Quality System Regulation
- ISO 14971:2007 Risk Management Certified
- EN ISO 14971:2012 Risk Management Certified
- Class I, II, and III devices, including Premarket Approval (PMA) products
- ISO 7 and ISO 8 Certified Cleanroom Controlled Environments