Documentation and Regulatory Reporting 

As a complete medical device product development resource, our services include  QSR documentation and Product Design Control support. We have a dedicated Regulatory Affairs Director, and we will work with each client company to provide necessary documentation (at appropriate points in the development process) to be sure that the requisite design controls are being exercised and adequately documented.    

Tracking and Design Control Documentation of all of the development stages of your medical device. 
The transition from feasibility to the start of the design and development phase is an area that needs close attention. We can help you set-up to meet the FDA Design Control Requirements.  

Design Control and Documentation assistance for:

• Risk Management

• FDA Requirements

• Design Input/Output

• Verification

• Validation

• Design Transfer 

• QSR requirements

    Kathryn Kulkulka, our Regulatory Affairs Director, suggests:
   An Introduction to Design Control an article from our newsletter, OMNIview.
   "It's a good overview of the Code of Federal Regulations".