Regulatory Compliance Associates Inc. has the experienced personnel and leadership capability necessary to plan and execute your medical product development needs. We will lead development from concept phase all the way through product launch. Alternatively, we will review existing projects and/or research and development procedures, and provide the necessary training required to streamline processes and increase the likelihood of project success.
Regulatory Compliance Associates Inc. offers a comprehensive list of product development services including:
- 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
- R&D Process Optimization for Increased Effectiveness and Efficiency
- Design and Development Standard Operating Procedure Development
- Regulatory Analysis and Filling Strategy Development
- Design History File Compilation
- Expert Problem Solving
- Design for Six Sigma