Medical Device Manufacturing
Partnering in design and development of medical devices
DSM has been manufacturing and assembling devices for over 25
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, formerly a Kensey Nash facility (DSM acquired Kensey Nash in 2012).
Worldwide medical device contract manufacturer
With lot sizes ranging from less than 10 to over 10,000 pieces, we manufacture over 4.5 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
Capabilities for medical device manufacturing
We have the following personnel and facilities to support your manufacturing needs:
- 15 Class 100,000 (ISO Class 8) cleanroom suites
- FDA registered and ISO 13485 certified
- Production staff to assemble, test, inspect and package products
- Product development and commercialization managers and engineers who help customers bring their concepts to the market
- Manufacturing engineering staff experienced in tooling, automation, project management, device fabrication, packaging and assembly
- Custom packaging to meet any branding, marketing or production requirements
- Coordinate sterilization of medical devices using gamma-irradiation, electron-beam (e-beam), and EO-gas methods
- State-of-art tooling equipment for the precise manufacturing of implants made of metal or engineered plastic materials
- Utilize existing machinery or design custom machinery to meet your product or production requirements
- A regulatory staff dedicated to ensuring FDA and ISO compliance; managing numerous US, EU, Canada and OUS submissions annually
- Quality assurance personnel who perform incoming, in-process and final inspections to assure full specification compliance on every lot of material received and shipped
- Sterilization validations, process validations, test method validations, transportation and packaging validations
cGMP-compliant implant manufacturing
Our dedicated cGMP-compliant implant manufacturing space includes CNC Swiss turn lathes, conventional CNC lathes 5- axis mills, laser marking and high-resolution measurement equipment.
