Product Management

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).

 

Our 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 Regulatory Compliance Associates

 

Regulatory Compliance Associates® (RCA) provides healthcare consulting 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, 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. 

 

 

Our website uses cookies to give you the best possible experience.

By continuing to use this site, you agree to the use of cookies.
Continue