FDA registered and ISO 13485:2016 registered
All facilities comply with all FDA QSR and ISO requirements for manufacturing medical devices.
- FDA
Martech is an FDA Registered Medical Device Manufacturer.
- ISO 13485:2016
Martech Medical is an ISO 13485:2016 registered company, and Martech West holds its own ISO certification.
- ISO Class 7
Molding runs in a class 100,000 (ISO Class 7) controlled environment.
Our Regulatory Department can assist with all phases of international product approvals, including FDA 510(k) and PMA, EU-CE, Canadian Licensing and Japanese Shonin. Certificates and the confidential disclosure agreement are on the current Martech site.
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Prefer to talk it through? Call (215) 256-8833.
- The part or device: a drawing, a part number or a description.
- Materials and dimensions: OD, ID, wall and tolerances for tubing.
- Quantity and timing: note that a $500 (US) minimum per item applies.