Regulatory Compliance Associates^® (RCA) MDR consulting service offerings to Assist Existing/New Clients with Implementation of the EU MDR requirements.

1. Perform a Comprehensive Review of Client’s Entire Product Portfolio:
   • Confirm whether any Legacy Products and/or Modified Legacy Products have been affected by the new MDR Definitions and/or Reclassification of certain types of products
   • Prepare Product Rationalization Strategy Reports
   • Check the status of MDD Certificate expiry dates and prepare an EU MDR Certificate Compliance Strategy for each product expiry date and prepare an EU Compliance Strategy for each device
2. Remediation and Implementation of EU MDR Compliance Plan
   • Supply Chain Requirement
   • Development/Implementation of an Compliance Plan for systems and devices
   • Remediation of Compliance Gaps
   • Development/Implementation of EUDAMED Database compliance plan
3. Staff Augmentation
   • Readiness Audits / Pre-Certification Audits and/or Assessments
4. Perform a Gap Assessment of the current Quality Management System (QMS) and its Current Processes and Procedures Compliance
   • Labeling requirements
   • Enter regulatory data into the EUDAMED Database
   • Post-Market Surveillance System (PMS)
   • FDA Unique Device Identification (UDI) System
   • Clinical Data
   • Vigilance Activities
   • Market Surveillance Activities
   • Safety and Performance

About RCA

Regulatory Compliance Associates^® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

We understand the complexities of running a life science business and possess areas of MDR consulting 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 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

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