Our proven track record for delivering exceptional medical device components demonstrates our commitment to superior quality and consistency in all that we do. We pride ourselves on delivering material science technologies and development services that meet the most stringent requirements to ensure every customer’s standards and deadlines are met every time. Key elements of our commitment to quality include:
- ISO 13485: Certified
- FDA Registered and compliant with the Quality System Regulation
- ISO 14971:2007 Risk Management
- EN ISO 14971:2012 Risk Management
- Class I, II, and III devices, including Premarket Approval (PMA) products
- ISO 8 Certified Cleanroom Controlled Environments
Quality Documents
- BSI Certification Fremont, Orange County, Costa Rica, Mexico, and Warwick
- Intertek Certificate of Registration, Windham, Maine
- Quality Manual
- RoHS Certification
- Material Safety Data Sheet
To request a copy of our ISO 13485 Certificate or Quality Manual, please contact our QA department
