Medical Device Quality Assurance and Regulatory Company


American Health Care Capital is proud to present an International Medical Device Consulting Group for sale. The company is an association of consultants with many years of experience in establishing quality systems and attaining market clearance for medical device companies in the US, Canada, and European regulatory markets. Their team of professionals have experience developing and defending quality systems in companies whose sizes range from Fortune 100 world-wide companies to start-ups trying to get their first product approved by FDA. They have an international presence with customers in Asia, Europe, and the Americas.

This medical device consultant company has developed a Lean Quality Management System suitable for companies in all phases, including the start-up (pre-product release), growth (product introduction and growth), and expansion (acquisition or multiple products) phase. This consulting group offers cloud-based document control, ideal for multinational companies who wish to have the ability to view quality system documents from anywhere in the world.

Quality and regulatory consulting is a fast-paced, evolving industry with more demand than competent suppliers. This international medical consultant company is balanced between gaining new customers through the current marketing plan and servicing current customers with a stable number of independent consulting associates. Future expansion is dependent on increasing the number of independent consulting associates. Their current team of associates ranges from ex-FDA 510(k) reviewers to seasoned Quality and Regulatory executives from Fortune 100 companies.

Over the last few years, the company has remained steady in volume, profitability, and client base. In 2019, Gross revenues were $362,621 with an adjusted EBITDA of $103,295. In 2020, Gross Revenues were $497,512 with an adjusted EBITDA of $184,921. In 2021, Gross Revenues were $441,466 with an adjusted EBITDA of $142,865. In 2022 for the first ten months, they had Revenue of $394,534 and an adjusted EBITDA of approximately $105,669, and they expect to gross $475,000 by the end of the year with an adjusted EBITDA of around $150,000.

This company has a very stable office and field staff that are all expected to stay on post-sale. The owner wishes to sell to pursue other business interests but will assist during a transitional period.

The asking price for this international medical device consultant is $300,000.

If you would like to learn more, please use the link on the right-hand side of the page to execute our NDA. You will need to copy the Listing Code (Example: TXMC1A) and Listing Title (Example: $1 Million Home Health Agency in Texas) from the summary above to complete the NDA.