Regulatory Mark provides regulatory advice and strategic guidance to medical device entrepreneurs, designers, and manufacturers.

With unparalleled expertise and years of experience, we supply our clients with viable and efficient solutions for medical devices and technology.

Regulatory Mark is different.

No business is the same. You have a product with a unique set of characteristics, and licensing and marketing it is not an easy task. Regulatory affairs and quality assurance for medical devices can become complicated and every step in this process is critical, time-sensitive and expensive.

At Regulatory Mark, we understand that.

Over the years we have developed a simple approach to our work that involves building long lasting business relationships with our clients and delivering only highly customized solutions. That’s why our first task is to understand your business goals and objectives. What you get are
leading edge regulatory and quality solutions tailored to your objectives and delivered on time and within budget.

Our Expertise.

With an experienced team of highly skilled consultants, our prime focus is to assist clients in all regulatory matters – from regulatory strategies for new products to Quality Management System solutions.

With experience in ISO 13485 and 14971, ISO/IEC 62366, FDA 21 CFR 807 (establishment and listing), 803 (MDR), 812 (IDE), 820 (QSR) and 1040 (laser products), MDD 93/42/EEC, MDR 2017/745, MDSAP, and CMDCAS, we partner with our clients to navigate the complex landscape of domestic and international regulation.