Australia, Brazil, Canada, China, Colombia, Costa Rica, Egypt, Europe, Hong Kong, India, Israel, Japan, Malaysia, Mexico, New Zealand, Peru, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Turkey, United States
Proudly serving small medical device manufacturers since 1997
For more than 15 years, we have been helping companies from Boston to Berlin to Tokyo grow and expand into new markets. We assist companies in all stages of growth, from startups seeking FDA 510(k) clearance for their first product, to established multinationals needing assistance with global regulatory strategy. However, our real passion is helping small businesses grow – getting them to the next stage of growth by introducing a new product or accessing a new international market.
75% of our clients have fewer than 100 employees.
You may see our website and assume we only serve larger medical device and IVD companies. In reality, the lion’s share of our clients are small, 50% of them having fewer than 25 employees. We love working with small companies because we enjoy being an integral part of helping the company grow and expand into new industry segments or markets. Startup and small companies that are not large enough for a full time QA or regulatory person often outsource their QA/RA responsibilities to us. Typically, one of our consultants will come on site a few days each month to ensure ongoing QMS and regulatory compliance.
We understand the needs of small medical device manufacturers.
We get it. Having worked with more than 2000 small to mid-sized medical device companies in the last 15 years, we know that money is often tight and that the investment in regulatory compliance has big implications for the future of the company. We respect that and appreciate the trust companies place in our expertise.
Global service, fair pricing.
We are not a law firm, and we don’t charge law firm prices. We know all too well that growing medical device manufacturers have far more needs than money to meet those needs. That’s why we charge a fair price for our services. In most cases, we charge a fixed flat fee for our services because we know that smaller businesses want to know exactly how much it will cost to achieve a specific goal.