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

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].