Documentation and Regulatory Reporting            to contact us, call  949-472-0275

As a complete medical device product development resource, our services include  QSR documentation and Product Design Control support. An in-house Regulatory Affairs Director 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.    

Kathryn Kukulka works with our entire team to make sure each of our clients has a quality control system in place, and that the entire development process is tracked and appropriately documented. 

Tracking and Design Control Documentation through all of the development stages of your medical device. 

A big challenge for medical devices manufacturers is understanding how to implement and integrate federal requirements with their existing systems. We can help you set-up a new or existing system to meet the FDA Design Control Requirements, and smoothly transition from feasibility to the start of the design and development phase. 

Our Project Design Control team can offer guidance to help ensure the final device or product design (the one released to production) meets the approved guidelines.

Design Control and Documentation assistance :

• Medical device documentation

• Quality control

• FDA requirements

• GMP requirements

• QSR requirements

• Risk management

• Design input/output

• Verification

• Validation

• Design transfer 

• 510 (K) documentation

Kathryn Kukulka, our Regulatory Affairs Director confirms,  "We will help you fully understand the FDA mandated QSR requirements, establish your design control system, and put it into practice."

 Read:   An Introduction to Design Control an article from our newsletter, OMNIview.