A partner you can trust from concept to commercialization

Contract Manufacturing

DSM has been manufacturing and assembling devices for over 30 years. During this time, we have successfully designed and developed numerous medical device products towards receiving 510K and CE mark approvals for U.S. and worldwide distributions. All our facilities are ISO 13485 certified and we have one FDA-registered manufacturing facility.  ​

Worldwide medical device contract manufacturer​

With lot sizes ranging from less than 50 to over 40,000 pieces, we manufacture over 3.5 million medical components annually. These components can be used worldwide in orthopedic, spinal, general surgery, dental, cardiovascular and other applications to facilitate healing and bone growth, and provide support after surgery.​

We specialize in:​

  • Manufacturing products from raw materials, to fully packaged and sterilized in a turn-key format​

  • Providing materials in a sub-assembly form to allow you to complete the final assembly​

  • Providing fully packaged and/or sterilized products using customer materials​

ISO13485:2016 Certified/MDSAP Certified/ISO Class 8 cleanroom suites​

In addition to being ISO certified (9001, 13485) and FDA registered, we avoid unnecessary delays, even with new submissions thanks to our MDSAP designation.​

Quality Assurance, Quality Control

With more than 3.5 million medical components manufactured annually, we assure full specification compliance on every lot shipped.​

DSM can support you every step of the way, from ideation through full commercialization

Partner with DSM
from concept to commercialization

 

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  • Our products

    DSM portfolio of innovative biomedical materials and process manufacturing technologies: Biomedical Polyethylenes, Biomedical polyurethanes, Collagen Technology, Device Development, and Extracellular Matrix (ECM) Technology. Learn more.

  • The markets we serve

    DSM Biomedical offers the broadest portfolio of biomedical materials and manufacturing across market applications, including orthopedics, ophthalmology, neurology, cardiology, diabetes, wound, and continence care.

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