Accelerate your product development.

Medical Device Risk Analysis, Management, & Design Control

Engineering Services

Device requirement generation is a useful and necessary step in the development process. We have experience with risk analysis, creation of user needs, design control file creation, process validation, clinical evaluations and many other activities as identified in ISO 14971 that are required to produce a safe medical device. We can help at any stage with the development of your medical device

Accreditation

  • ISO 13485