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Quality Management System Consulting for Medical Device Companies

The FDA requires medical device companies to follow cGMP requirements and implement a Quality Management System (QMS) that demonstrates 21 CFR Part 820 compliance. This includes regulations for developing, manufacturing, packaging, labeling, storing, installing and servicing medical devices intended for human use. Complying with FDA Quality System (QS) Regulations ensures your product consistently meets regulatory requirements as a medical device manufacturer.

MethodSense offers a wide range of Quality Management System (QMS) Consulting Services for Medical Device Companies:

Achieving an auditable standard of quality is a significant challenge for medical device manufacturers. We focus on enabling our clients to achieve the required levels of product quality in a way that delivers both operational excellence and an accelerated achievement of your goals with practical, implementable solutions.

We also know firsthand that the most difficult aspect of compliance is maintaining it. Every year – every month – every week, there are actions that must be taken to demonstrate you’re in compliance with your Quality System. MethodSense can be part of your virtual quality team to ensure your auditability. Learn more about our On-Call Quality Support services to see if they are right for you!

For a complete review of your medical device company’s QMS.