Product Life Cycle Management (PLM) is the systematic approach to effectively manage the series of changes your product may go through from its early concept phase through design and development, to commercialization, and ultimately up to the product’s end of life and/or obsolescence. Regulatory Compliance Associates® Inc.’s approach to medical device PLM includes the application of different strategies to help meet the challenges you may face during the life cycle of your product(s).

 

medical device PLMOur Product Life Cycle Management Services include:

 

  • Project Leadership
  • Prototype Development
  • Risk Analysis
  • Integration of Risk Mitigation into Product Development
  • Design Verification and/or Validation Test Protocols
  • Design Review Planning and Facilitation
  • Change Management
    • Changes to Comply with New Standard
    • Design Enhancements
    • Cost Reduction
    • Obsolescence
    • Change to Address Complaint Backing
  • R&D Process Optimization for Increased Effectiveness and Efficiency
  • Design and Development of Standard Operating Procedure Development
  • Regulatory Analysis and Filing Strategy Development
  • Design History File Compilation
  • Expert Problem Solving / Root Cause Investigation
  • Medical device PLM Design for Six Sigma
  • Post Product Release Risk Management
  • Regulatory Post Product Release Support
  • Remediation Strategy and Support
  • End of Life Strategy and Implementation
  • Independent Product Verification and Validation

 

About RCA

Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

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-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

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