delivering breakthroughs within the life sciences | 919.313.3960

the medical world is changing...

keep up with evolving regulations to ensure you get to market without unnecessary delay

meet regulatory requirements…

establish practical ways to achieve an auditable standard of quality for the lifecycle of your business

demonstrate safety & performance...

by ensuring key business systems and product technologies function as intended for compliance

risk is always a factor...

reduce risk of liability with well-documented safety standards and risk management practices

deliver on the quality you promise...

by proactively addressing the integrity of your data management policies and procedures

MethodSense delivers life science and medical device regulatory compliance consulting designed for you to get compliant – and stay compliant.

MethodSense is a life science consulting firm with offices in the US and Europe. We guide medical device, biotech and pharmaceutical companies with quality, regulatory and technology solutions. Our regulatory compliance consulting enables clients to operate more effectively during the commercialization process and beyond. 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.