Regulatory Consulting, Pharmaceutical Consulting, Medical Device Development
Regulatory requirements impact your products – and your business – throughout their entire lifecycle. Especially when you consider that regulations are constantly changing. A single regulatory misstep or misunderstanding may stand between your financial success and misfortune.
Our regulatory professionals work with you to develop and execute a roadmap to commercialization by ensuring you meet the evidentiary requirements that demonstrate the safety and efficacy of your medical device. Our experience covers regulatory requirements of the US, Canada and Europe.
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From 21 CFR Part 11 to AlCOA, MethodSense can help you practically implement the processes and plans designed to both achieve compliance and support data integrity.
MethodSense mitigates your risk by ensuring key business systems and product technologies function as intended and comply with regulations.
Rita King, our CEO, participated in the development of safety critical software standards for UL and ANSI, giving us key insight into how certification is achieved.
ISO 13485 Quality Certification is required for medical device companies as a qualification to market medical devices in most non-US
At MethodSense, we’ve developed practical regulatory solutions which allow you to meet high levels of product quality and auditability.
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