take the right compliance steps to ensure the safety, effectiveness and availability of your products during the commercialization process.
meet the regulatory requirements necessary to bring your product to market by implementing proper Quality Management Systems.
mitigate your risk by ensuring key business systems and product technologies function as intended and comply with industry regulations.
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 services enable clients to operate more effectively during the commercialization process and beyond. From 510(k) submissions to IEC 60601-1 A1 tables and Software Development Lifecycle Management to Quality System Management, our life science and medical device consultants have the expertise to help you bring your product to market with unnecessary delay. Contact us today to learn how we can help you!
satisfy US and global authorization requirements
achieve product quality standards and operational efficiency
minimize risk with compliant business and product technologies
> 510(k) submissions
> 21 CFR Part 11
> 21 CFR Part 820
> IEC 60601-1
> IEC 62304
> ISO 13485
> ISO 14971
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