ISO certified. FDA cGMP compliant.
At Actuated Medical, our goal has always been to integrate the systems of a large company with the agility of a small company. Here is what sets us apart from most early-stage product development companies:
- ISO Certified – All of our products are designed, tested and manufactured using proven ISO–certified quality control and risk assessment systems.
- FDA cGMP Compliant – Our proven 7–stage Product Development Cycle is FDA cGMP compliant.
- Clinical Focus – Every step of the way, we work with clinicians to ensure our products solve real–world problems and are rapidly accepted.
- Well–Rounded Team – In addition to clinicians, application engineers and scientists, our team includes experts in medical device quality assurance, regulatory affairs, reimbursement strategy, intellectual property, manufacturing scale–up, and customer post–market surveillance.
Proven 7–Stage Product Development Cycle
Sound Business Model
We maximize return on capital by funding a majority of our early technology development through non–dilutive federal contracts (over $14MM secured to date). Then, we use private funds to carry products through the final stages of our product development cycle into the market. Our goal is to develop products from concept through early, targeted sales and then partner with market leaders for larger–scale sales, marketing, and distribution.