Design and Development Process
Product design and development is perhaps the most important phase of the medical device lifecycle. Too often, companies fail to properly document the product's design leading to needless delays in the product's development or compliance risk after launch.
We develop and implement a design and development process for manufacturers of medical devices including IVDs (in vitro diagnostics) and combination products under ISO 9001/ISO 13485 and the Quality System Regulation (QSR).
We have worked with a variety of manufacturers from start-ups to Fortune 100 companies to establish design and development processes, conduct design and development process audits and perform remediation of deficient design history files. The following are some of the services we provide in this area:
- Design and Development Process Implementation
- Design Control Audits
- Design and Development Plan
- Design and Development Project Management
- Regulatory Standards Assessment
- Device Master Record (DMR)
- Risk Management Program Development and Implementation (EN ISO 14971)
- Design History File Compliance and Remediation
- Biocompatibility/Sterilization Assessment
- Effective Design Change Control Practices
- Design Transfer Practices