MEET ISAAC ERICKSON, MBS
An Expert Regulatory Consultant for Medical Devices
With a Master’s degree in Biological Sciences and a specialization in robotics, Isaac brings a unique blend of technical expertise and regulatory insight to the medical device and biotech industries. As a trusted consultant, he provides strategic guidance on FDA 510(k) submissions, Premarket Approvals (PMAs), international product registrations, like EU MDR, and regulatory strategies—helping companies streamline approvals, mitigate risks, and accelerate market entry. Isaac’s expertise ensures that your medical device meets regulatory standards and achieves commercial success in competitive global markets.
Proven Experience in Product Development & Commercialization
Isaac has authored and submitted numerous FDA 510(k) premarket notifications across a wide range of medical technologies, including medical autoclaves, sterilization wraps, laparoscopic irrigators, self-fitting hearing aids, biomicroscopic instruments, and Software in a Medical Device (SiMD). His experience spans the full regulatory lifecycle—from device classification and risk management to biocompatibility, sterilization validation, and software documentation—utilizing the FDA eSTAR program to streamline submissions. Isaac’s expertise also includes biocompatibility, cybersecurity risk assessment, software validation, quality system compliance, and substantial equivalence justification for both hardware and software-based medical devices. As a medical device regulatory affairs consultant, he applies a strategic, compliance-driven approach to ensure FDA readiness and successful market access.
Beyond regulatory affairs, Isaac’s background in lab equipment, medical device product development, and robotics positions him as a valuable partner. Incubators, centrifuges, PCR machines, and sterilization equipment—some of which have been featured on TV shows like CSI: Miami and Zoo, highlighting the impact of innovative design and regulatory excellence. Isaac’s leadership in developing cutting-edge laboratory instrumentation ensures that companies bring high-quality, compliant, and market-ready products to life.
TESTIMONIALS
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Support Tailored To Your Regulatory & Innovation Goals
Whether you need assistance with a Class I registration, FDA audit, 510(k) submission support, De Novo, PMA, EU MDR, or international regulatory navigation, Isaac Erickson offers tailored consulting services to help you achieve your goals efficiently and effectively. Let’s turn your vision into a fully compliant, market-ready success.