Documentation and Regulatory Reporting           

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, as you transition from feasibility to 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.

More Information from Kathryn Kukulka, our Regulatory Affairs Director:

"While Omnica makes every reasonable effort to ensure the accuracy and professionalism of our service, and the efficacy of the designs that result from our creativity and experience, the client manufacturer bears the full and final responsibility for determining the suitability, safety, marketability, and overall fitness of the design for any intended purpose. The client manufacturer of a medical device is also responsible for developing a Quality System based on the 21 CFR Part 820. Many also choose to become ISO 13485 Registered.

We typically prepare a quality manual specific to the
client manufacturer with whom we be will working.

We are keenly aware that our client manufacturers are required to follow the law and the Omnica quality system follows the model of the QSR with reference to ISO 13485. Because Omnica is not a manufacturer however, we are not required to be ISO 13485 Registered, nor to follow current good manufacturing practice (CGMP) requirements set forth in the Quality System Regulation (QSR)."

Design Control and Documentation assistance related to:

• Medical device development

• FDA requirements

• QSR requirements/Quality control

• Design input/output

• Risk management

• Verification

• Validation

• Design transfer 

• GMP requirements

• 510 (K) documentation support 

Kathryn Kukulka, our Director of Regulatory Affairs 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.