Medical Device Consulting
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. To guide you, MethodSense delivers medical device consulting services, including regulatory, quality and process consulting to expedite FDA and international regulatory submissions.
In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully. Regardless of where you are in the commercialization process, or how many products you’ve brought to market, MethodSense knows where to focus our experience to best assist you.
Bring Your Medical Device to Market
- Get FDA Clearance (PMA, 510(k), de novo)
- Establish GxP Controls
- Meet Human Factors Requirements
- Meet ISO Standards
- Test and Validate Technology
- Comply with Safety Standards
- Create an Auditable Quality Management System