Regulatory Compliance Associates® Inc. provides program oversight and resources to assist with remediation activities for technical file inadequacies or legacy Design History Files (DHF). From launching new products to updating design information to validate and maintain a device through its lifecycle, we have a thorough understanding of the requirements to ensure regulatory compliance.

 

Design History File Consulting

Our technical file and Design History File related support services include:

 

  • Design Input Analysis
  • Design Output Analysis
  • Risk Management: Use, Design, and Process
  • Design Validation Testing
  • Essential Requirements Checklist
  • Product Specifications
  • Design Verification Testing
  • Process Validation

 

About RCA

design history fileRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

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