Regulatory Compliance Associates (RCA) is widely recognized within the life science industry for its ability to help companies successfully resolve complex regulatory and quality compliance challenges.
Medical Device Remediation Consulting
With a proven track record of medical device remediation success, our life science consultant experts have significant experience developing responses and implementing action plans to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees. Our team, which includes former FDA officials, brings extensive experience in remediation services, distinguishing us in the complex landscape of regulatory challenges faced by medical device manufacturers. We partner with companies of all sizes, from startups to Fortune 100 firms, to help them enhance patient outcomes while ensuring compliance throughout their journey to market.
Quality System
Whether under official or voluntary action indicated, Regulatory Compliance Associates® (RCA) routinely develops and executes scalable, defendable Quality System remediation plans for medical device manufacturers. Regardless of an organizations size,...
Design History File
Regulatory Compliance Associates 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...
Regulatory Response
Regulatory Compliance Associates Inc. (RCA) is recognized within both the medical device industry as well as the regulatory agencies for its ability to help companies successfully resolve regulatory challenges. With...
21 CFR Part 11
Regulatory Compliance Associates® (RCA) computer system validation experts and software engineers have extensive experience with 21 CFR Part 11 and the GAMP5 validation model. System Validation analyzes the data integrity...
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