Monitoring the safety and effectiveness of your medical device after it has been commercialized requires the implementation of effective Post Approval Support processes. These strategies and activities are specifically designed to ensure the ongoing compliance of your product(s). Regulatory Compliance Associates® (RCA) can help you design, implement, and execute a Post-Market Support Strategy including:
- Corrective and Preventive Action (CAPA) Support
- Root Cause Investigation
- Audit / Inspection Preparation and Remediation
- Labeling Review and Assessment
- Post-Market Surveillance (PMS)
- Medical Device Reporting / Adverse Event Reporting
- Recall Management
- Complaint Handling
- Re-submission Assessment and Remediation
- Post Approval Support
About Regulatory Compliance Associates
Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:
- Life Sciences
- Biologic & Biotechnology
- Sterile compounding
- Medical device
- Lab Testing
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, Health Canada, MHRA 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
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
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.