Isaac A Erickson, MBS

Regulatory Affairs Consulting

651-353-7806

About Isaac Erickson - Expert in Medical Device Regulatory Strategy & FDA Compliance

As the President of IMDS Consulting, I am dedicated to ensuring that medical devices achieve and maintain stringent FDA compliance. My expertise spans a comprehensive range of regulatory submissions, including 510(k) clearances, Class I and Class II device submissions, and Class III PMA applications. I also specialize in medical device labeling, UDI implementation, and navigating international product registrations.

At the intersection of regulatory strategy and device innovation, I leverage extensive experience in robotics, medical devices, and life science instrumentation. My responsibilities encompass driving product development with a strong focus on marketability and compliance. Through strategic regulatory planning, I provide expert guidance in product design, software development, and the 510(k) and PMA processes, enabling seamless FDA clearances and strengthening the competitive standing of our clients.

Specialization: FDA Clearances, eSTAR Applications, and PMAs

With a proven track record of securing FDA approvals, I specialize in preparing and submitting eSTAR applications that expedite the FDA review process. My experience extends to Class I and Class II submissions, PMAs for Class III devices, medical device labeling, and implementing UDI requirements. I also have hands-on experience in managing foreign product registrations in markets such as Mexico, Peru, and Colombia.

Leadership in Life Science Instrumentation & Product Development

My commitment to operational excellence is evident in my leadership role, where I oversee the development of innovative laboratory products and cutting-edge instrumentation. My background in robotics and biotech product development includes designing automated DNA extraction systems, PCR machines, and sterilization equipment, some of which have been featured on TV shows like CSI: Miami and Zoo. These accomplishments reflect the impact of strategic design and comprehensive regulatory planning.

A Comprehensive Approach to Regulatory Compliance & Innovation

With a Master’s degree in Biological Sciences and a specialization in robotics, I combine technical proficiency with in-depth regulatory knowledge to drive innovation in a global landscape. My consulting services offer comprehensive support in FDA submissions, PMAs, foreign product registrations, and more, ensuring that your medical device products not only meet compliance standards but also achieve market success.

15 Years Experience

510(k) Authorship and Clearance

Masters In Biological Sciences

Limited Liability Company

Insured

Client Reviews

"Isaac has been a great resource for my company.  We manufacture class IIa IIb devices around the world.  The most recent 510(k), which Isaac assisted, resulted in only three minor deficiency questions, all three of which took a total of 35 minutes with the FDA reviewer to answer!" 

-Gregg, ThermaSolutions

"Working with Isaac has been incredibly valuable for our company. His combination of practical insight and technical expertise helped us navigate regulatory challenges and identify several viable paths forward. His guidance has been instrumental in clarifying our options and next steps."

- Sameer, HabitAware

"I've collaborated with Isaac on multiple projects over the years and can confidently say that he possesses extensive knowledge and expertise in 510(k) regulatory submissions. Isaac is very well versed in the FDA 510K process."

- Don, High Power Laboratories

"It is a pleasure for us to have IMDS Consulting as our consulting services supplier. Isaac´s expertise was intrumental in securing a recent 510(k) clearance and navigating multiple Class I registrations with precision and efficiency.

During this time, we have always received a cordial and respectful treatment and we have had timely responses to each of our requests, demonstrating their professionalism and excellence in all areas.

- Clarisbeth, Comercializadora Brever