Regulatory Compliance Associates® Inc. has a flexible and efficient approach to new 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
- 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
Regulatory Compliance Associates® Inc. (RCA) provides worldwide 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 private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.