This webpage provides history about our company and explains our approach toward quality and regulatory consulting.
Consulting services provided by our company
Our company is a quality and regulatory consulting firm. We have nine (9) employees, and everyone works virtually from home. We specialize in helping small device companies prepare FDA 510k submissions using the eSTAR template, preparing FDA pre-submissions using the PreSTAR template, implementing new quality systems for compliance with the FDA, ISO 13485, and MDSAP, and conducting quality system audits. We also help with FDA US Agent services, CE Marking preparation, and Canadian License applications. Clients with urgent needs where time to market is critical turn to us. Our passion is teaching medical device professionals how to prepare for future regulations. For more information, please visit our website or our YouTube channel. We even wrote a 510k book, “How to prepare your 510k in 100 days,” because 100 days is how long your testing will take. It is only available as part of our 510k course series, and you can find all the details on our 510k course webpage.
What does our company charge for medical device consulting and quality system procedures?
We charge $17,500 for preparing a medical device 510k submission. This pricing does not include pre-submission meetings or the FDA user fees for FY 2025. A table with user fees is found below as well. A button for our standard pricing sheet of consulting services is provided below, along with a second button for our turnkey quality management system (QMS) pricing.
We are affordable because we know your start-ups have “one egg and one basket.” We are casual. We like taking risks. We are irreverent. We make mistakes, but we learn from them. We want our work to be fascinating. We teach the most boring topic on planet Earth, but we refuse to be boring. We want to be remarkable, memorable, and fun to work with. Our team is primarily located in the Eastern Time Zone, with medical device consultants in North Carolina, Pennsylvania, New Jersey, and Vermont. We all work 100% remotely, and we always have.
Who is our ideal medical device consulting client?
We are a full-service medical device regulatory consulting firm. The name “academy” emphasizes our love for training. We specialize in helping entrepreneurs get their first product to market–regardless of whether that is a medical device 510k clearance or a De Novo Classification Request. Ideally, you are located in another country, and you need help understanding the requirements of the US FDA. The best time for you to contact us is at the early stages when you have a proof-of-concept prototype but are unsure what to do next. You also might be under-capitalized, and you need advice on how much to budget and how to use your limited funding most efficiently.
What do our quality and regulatory consultants do?
Most of our work is preparing regulatory submissions, but 20% of our work involves helping you implement your quality system. We can help you with your medical device regulatory submissions. We specialize in medical device 510k submissions, preparation of CE Marking Technical Files, and Canadian device license submissions. We also created a business unit that specializes in preparing and validating FDA eCopies for pre-submissions, 510k submissions, and De Novo Applications. Due to changes in the FDA eCopy policies, we no longer offer FDA eCopy services except to active medical device consulting clients. If you need to upload your own FDA eCopy, you can register for a Customer Collaboration Portal Account with the FDA so that you can upload your own submission documents electronically.
Most of our clients are small and mid-size medical device companies that need continuing education training and quality System Auditing for compliance. Clients with urgent needs where time to market is critical turn to us. Our passion is teaching medical device professionals how to prepare for future regulations and self-monitor compliance to avoid compliance remediation.
How is our company different from other quality and regulatory consultants?
Most medical device consultants work by the hour, while our firm has flat-fee pricing. We can do this because we specialize in a narrow niche–primarily medical device 510k submissions and De Novo requests. We also differ from independent consultants and law firms because we have designed and built medical devices. Rob Packard was CEO and co-founder of a medical device start-up in 2004.