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Latest News and Insights from MethodSense

Why MethodSense?

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

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

Our Services go Right to the Core of Your Businessss

Your ability to sell–and keep selling–your innovation depends on maintaining regulatory compliance and quality programs. That’s where we come in
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...

Some people might call it regulatory compliance or quality programs–but we can 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!

Regulatory Compliance Consulting

Regulatory Compliance Consulting

FDA submissions, CE marking and risk management consulting
Quality Assurance and Regulatory Compliance Consulting for Medical Device Manufacturers

Quality Assurance

Meet FDA 21 CFR Part 820, ISO 13485 quality requirements and more
Medical Device Technology Management and Regulatory Compliance Consulting

Technology Management

Achieve 21 CFR Part 11, ISO 62304 and SDLC requirements

Regulatory Compliance Goals

Take the right regulatory compliance steps to ensure the safety, effectiveness and approval of your products during the commercialization process.

Achieve Auditable Results

Meet regulatory compliance requirements necessary to bring your product to market by implementing the appropriate Quality Management Systems.

Pass Safety Standards

Mitigate your risks by conforming to relevant technology standards for testing and certification, such as IEC 60601-1 and ISO 14971.