Regulatory Requirements for Medical Device Technology Validation
Medical device commercialization increasingly incorporates technology solutions subject to FDA review involving standards testing, technology validation and software validation. Regulators are putting added pressure on medical device companies to demonstrate that their technologies perform safely and as intended. Changes in regulations and in the functionality of technology have made it difficult to successfully meet auditors’ demands unless you have a good technology management program.
Our medical device technology consultants guide medical device companies with:
- 21 CFR Part 11 and Part 820 compliance strategies
- Medical device safety testing management
- Process and software validation development and execution
- Design of software controls to meet your design control needs
- SDLC methodology optimization for your regulated environment
- Technology assessments for procurement or acquisition
Implementing a technology management program helps your medical device company:
- Attain regulatory compliance
- Identify potential risk factors
- Reduce application development time
- Improve business efficiency
- Provide a qualified, third-party analysis of your systems
At MethodSense, our technology and software experience grew from the development and productization of InfoStrength Smart Enterprise Suite, a SaaS document management solution for regulated businesses. It’s been further refined through building custom applications for our clients and preparing numerous technology products for market authorization.