Regulatory Compliance Associates® Inc. has a flexible and efficient approach to product development designed to meet the demands of fast time-to-market with an uncompromised approach to quality.


How We Work

  • Our engineers take on all or part of product development projects
  • We hit the ground running with expertise that spans all areas of medical device product development
  • You dial into our experts for just what you need without carrying the expense of an employee
  • We deliver compliant R&D which works with your quality system because we have deep backgrounds in RA / QA, in addition to engineering

What We Do

  • Speed up the product development cycle—especially when internal stakeholders are driving for faster launch dates than the development team can deliver
  • Augment the internal team’s skill set without the overhead of full-time employees
  • Save costs over typical outsourced design firms because you use the experts you need, when you need them
  • Provide flexibility to take on complete development from concept to market or specific design phase as required

The RCA team giving a client the rundown of our services with strategic consulting for new product development.

Our Services

  • Full Product Development including Risk Management, Design History File, Validation, and Verification including Software Validation
  • Regulatory Path including Submissions
  • Supplier Sourcing and Qualification
  • Manufacturing and Manufacturing Transfer
  • Post-Market Surveillance
  • Software and mHealth Apps


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