Services in Medical Device Development
Perficio Product Development can assist you in the development of your medical device across all the required disciplines, or in individual aspects of development.
For Research and Development Perficio Product Development can assist in the identification and prioritisation of specific tasks to fast track commercial development opportunities. We can also conduct Research and Development for customers requiring assistance with new ideas or concepts.
Please scroll down or click on the links to learn more about our services.
Planning Phase
- Project definition and scope
- Project planning
- Analysis of current product or new product concept and identification of development priorities
Design Phase
- Detailed system, subsystem, and module specifications
- Detailed functional analysis, architecture definition, and physical definition
- Detailed engineering design (electrical, mechanical, and software)
- Specialty engineering (risk, reliability, safety, maintainability, and ILS work)
- Detailed design description
- Risk Management (FMEA/FMECA, FTA, Hazards Analysis)
- Analysis of current product or new product concept and identification of development priorities
- Configuration management
- Definition of the Design History File
Verification & Validation Phase
- V&V plans, protocols, reports, and summaries (for each requirement level)
- Conduct of V&V activities
Regulatory Submission Preparation
- Development of technical files and other regulatory data as required by your regulatory strategy
Market Release Phase
- Analysis of product performance
- Assistance with implementation and use of FRACAS and CAPA Systems
- Assistance with product failure analysis
- Risk Management (analysis and update of product risks and hazards)