Medical Device Remediation Consulting
Regulatory Compliance Associates (RCA) is widely recognized within the life science industry for its ability to help companies successfully resolve complex regulatory challenges, including Quality Compliance challenges. 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.
Each consultant understands the difficult demands of remediation services and the time constraints involved with execution. Our extensive experience makes partnering with Regulatory Compliance Associates a competitive differentiator in the remediation space.
Get to Market Sooner With RCA
Medical device manufacturers can help medical professionals save lives and improve the quality of life for their patients. But these positive results can only be achieved if they first successfully navigate the regulatory challenges that lie ahead of them on their way to market. This is why the team at Regulatory Compliance Associates, with experts that include former FDA officials and other leaders in the medical device regulatory field, can make a significant difference in the success of companies ranging from startups to international Fortune 100 companies.
Set up your Scoping call today. Contact Us Now
RCA can provide needed Medical Device remediation expertise and services in the following key areas:
- Quality Systems
- Technical File and Design History File (DHF)
- Regulatory Action
- 21 CFR Part 11 & Computerized System Validation
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].
