Frequently Asked Questions
Answers to common questions about our services, pricing, and how we work.
General Questions
Yes! We specialize in helping early-stage medical device companies navigate the
regulatory landscape. We understand the budget constraints and agility required for
startups and tailor our services accordingly.
Absolutely. While we are based in Albuquerque, NM, we work with clients globally using
secure cloud-based tools for document collaboration and video conferencing for meetings.
We can also travel for on-site audits or critical meetings if needed.
Services & Pricing
We offer both project-based fixed pricing and hourly rates, depending on the nature of
the work. For defined projects like a 510(k) submission, we typically provide a fixed
quote so you have budget certainty. For ongoing support, we can work on a retainer or
hourly basis.
Yes, this is one of our core areas of expertise. We can perform a gap analysis of your
existing MDD technical files against MDR requirements and help you remediate your
documentation, including CERs and PMS plans.