There is heightening pressure on life science companies to demonstrate that their technologies perform as intended and that all risks are mitigated or justified. With health care products incorporating more and more software technology solutions, the software regulatory landscape continues to expand. This includes the recent FDA Mobile Application Guidance, IEC 62304 software development management for electromechanical devices and the soon-to-be-released IEC 82304 for medical device software not dependent on hardware. MethodSense mitigates your risk by ensuring key business systems and product technologies function as intended and comply with regulations. Our experience in technology and software management grew from our founders’ development of InfoStrength Smart Enterprise Suite, a life science business application. We’ve also built multiple custom software applications and prepared numerous technology products for market authorization.
Minimize your risk by focusing on technology management:
- 21 CFR Part 11 and Part 820 Compliance Strategies
- IEC 60601-1 3rd Edition and IEC 62304 Product Safety Testing Documentation
- Process, Manufacturing, and Software Validation Development and Execution
- Design of Software Controls for Compliance Needs
- SDLC Methodology Optimization
- Technology Assessments for Procurement or Acquisition
SCHEDULE AN APPOINTMENT WITH ONE OF OUR MEDICAL DEVICE SAFETY CERTIFICATION CONSULTANTS TODAY to ensure your device gets to market quickly and without unnecessary delay.