We share with our clients more than 20 years of business and regulatory experience through supporting manufacturers of active medical products in global market access. AI-powered medical devices are our passion and focus. Hence, we work with medical software manufacturers and more traditional medical devices. It is very difficult to navigate in a strongly regulated industry like the medical industry and even harder to be successful in this industry. Combining business acumen and a deep understanding of medical regulations RASC consultants are able to work with Med-Tech companies developing cutting-edge technologies for digital health on product concept definition, business strategy development, and

execution. We deliver our customers a wide range of business analyses concerning legal requirements, competitive landscape, reimbursement pathways, Clinical Practice Guidelines, Key Opinion Leaders, and research partners. Successful technology companies include these data in their go-to-market strategy.

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With an extensive background in Regulatory Affairs for active medical products and support of companies in Global market access, we can provide support to any company developing an active medical device. We offer not only expertise in product safety evaluation projects, certification, and registration including FDA, but also support to companies wishing to develop and implement Quality Management and Information Security Management Systems in accordance with international requirements.
Among the certification and registration services that we offer you will find safety evaluation and certification projects under EU MDR [Regulation (EU) 2017/745], active medical device registration at the FDA, Health Canada, ANVISA, TGA Australia, and other. We do support our customers who develop active medical products with wireless connectivity in obtaining certification required by the U.S.

Federal Communications Commission, Industry Canada, RED EU, Anatel, and others. We can develop and implement the Quality Management System according to the requirements of ISO 13485 and CFR Title 21, Part 820. We support companies interested in implementing Information Security Management System according to ISO27001. We have extensive experience in surveillance and certification audits conducted as either internal or external audits. We worked with FDA on the FDA inspections and we have extensive experience with audits conducted under Medical Device Single Audit Program (MDSAP).


Market Access

EU, UK & Swiss Authorized Representative

Strategic and Business Planning

Regulatory Strategy and Development Planning

Reimbursement Pathways

Regulatory Outsourcing

Product Certification

Product Registration

Product Compliance Consultations

Wireless Connectivity Certification

Quality Management System

Information Security Management

Surveillance & Certification Audits

Corrective and Preventive Actions (CAPA)


  • We are professionals who completed more than 350 Market Access and Regulatory Affairs projects

  • Our project management team consists of people with a minimum of 10+ years of experience

  • All team members managed projects in an international environment and worked with customers aiming to globally commercialize their products

  • We work with Regulators, Notified Bodies, and Testing Laboratories from 5 continents

  • So far we enabled medical device manufacturers to access more than 45 countries