Our consulting team offers services in three key areas: 1. Regulatory Submissions (e.g., Breakthrough Device Designations, 513(g) submissions, Pre-Submissions, 510k submissions, Human Factors Documentation, De Novo Applications, CE Marking Technical Files, and Canadian Medical Device License Applications) 2. Regulatory Compliance (e.g., mock FDA inspections, ISO 13485 certification, and CAPA) 3. Continuing Education Training – webinars, public and private in-house training courses. 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 Eastern Time Zone, with employees in Florida, North Carolina, Pennsylvania, New Jersey, Tennessee, Kansas, and Vermont. We all work 100% remotely, and we always have. Our firm has three teams: FDA 510k Consultant Team, Human Factors Team, and a Sales Team. We have ten (10) full-time employees and one (1) part-time employee. Five of the employees are qualified lead auditors and one is in training. We have four (4) additional subcontractors that are qualified lead auditors.
