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Implementation of the EU MDR (2017/745) Requirements

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Implementation of the EU MDR (2017/745) Requirements

Implementation of the EU MDR (2017/745) Requirements

RCA Service Offerings to Assist Existing/New Clients with Implementation of the EU MDR Requirements

RCA may assist existing and new Clients with the following new services related to 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 dates 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 EU MDR Compliance Plan for systems and devices
    • Remediation of EU MDR 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
    • Data entered into the for EUDAMED Database
    • Post-Market Surveillance System (PMS)
    • FDA Unique Device Identification (UDI)System
    • Clinical Data
    • Vigilance Activities
    • Market Surveillance Activities
    • Safety and Performance

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