A partner you can trust from concept to commercialization

Regulatory filing & clinical trial support​

DSM’s experienced Clinical and Regulatory Affairs Staff has a proven track record of achieving US and foreign regulatory approvals. Implementing our regulatory strategy has involved conducting large and small-scale clinical trials with leading medical institutions throughout the world.​

Whether seeking regulatory approval independently or in collaboration with our valued sales partners, DSM can provide:​

  • Regulatory strategy consultation​

  • U.S. and International regulatory filing ​

  • U.S. and OUS clinical trials​

  • Clinical evaluation reports per ISO 14155​

  • Clinical investigation plan development and trial management

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Listen to Jodi Raus, Senior Director of Global Clinical & Regulatory, discuss how DSM Biomedical Solutions provides clinical and regulatory services for internally developed devices and in support of our partners​.

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Listen to Jodi Raus, Senior Director of Global Clinical & Regulatory, discuss how DSM is compliant with both the EU Medical Device Regulation (MDR) and Medical Device Single Audit Program (MDSAP).

IDE preparation/clinical trials/Clinical Evaluation Reports

Committed to the highest standards, we leverage our team of in-house experts who have conducted clinical trials under IDE regulations for 20+ years.

Regulatory support and/or approvals

With more than 20 material and device master files and over 45 regulatory clearances across 40+ countries, leveraging our regulatory support for PMA, 510k and CE Mark can enable faster time to market.

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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