regulatory and quality system professionals | 919.313.3960

Why MethodSense?

MethodSense is a unique combination of people, processes and technology–
specifically focused on the medical device and life science markets.

We ensure regulated companies have the processes and tools
to commercialize, sell, and continue selling their products.

Some people might call it regulatory compliance or quality programs–but we call it business fundamentals.

Domestic and international regulations are changing faster than ever. You need to manage the commercialization of your product and grow your business. And one mis-step can have grave implications. But MethodSense has the resources to help improve your people, processes and core valuation.

From 510(k) submissions to IEC 60601-1 tables and Software Development Lifecycle Management to Quality System Management, our life science and medical device consultants have the experience to help you bring your product to market without unnecessary delay. Contact us today to learn how we can help you!

We're your business partner

Our experts leave no stone unturned as they solve your immediate need and then turn to ensuring your future success. From the production floor to the board room and beyond—let the MethodSense difference be your competitive advantage.

Learn More About our Methods

Latest News and Insights from MethodSense

Accessory or Component and the FDA – The Fine Line Between Them

Accessory or Component and the FDA – The Fine Line Between Them

Determining if your product or innovation should be considered a component or an accessory is a critical early-life cycle inflection point. In fact, the distinction between the two terms has long been the subject of debate and interpretation. In August 2017, the FDA...

Our goals are your goals: grow your business with the best people, scalable processes and smart technology.

Here are few ways we help our clients:

Regulatory Compliance Consulting

 FDA submissions, CE marking and risk management consulting


Quality Assurance

Meet FDA 21 CFR Part 820, ISO 13485 quality requirements and more


Technology Management

Achieve 21 CFR Part 11, ISO 62304 and SDLC requirements