🎯 The business: you handle the regulatory path for medical device companies too small for a regulatory department: classification, the 510(k) or De Novo submission, the quality system, and the audits. Biomedical engineers with a few years inside a device company or the agency bill $150 to $300 an hour for this, from a laptop.
Device startups between their prototype and their first sale, often funded and on a deadline, plus small established manufacturers who need help with a new product or a warning letter. A 510(k) project runs $30,000 to $100,000 in consulting; a quality management system buildout $25,000 to $75,000; a fractional regulatory lead role $5,000 to $15,000 a month.
| Professional liability insurance (errors and omissions) | $2,000 to $5,000 a year |
| LLC, contracts reviewed by an attorney | $1,500 |
| Regulatory Affairs Certification, optional but persuasive | $500 to $1,000 |
| Standards library (ISO 13485, 14971, IEC 60601 as needed) | $1,500 to $3,000 |
| Website with case studies, a clean template library | $1,000 |
| All-in | ≈ $7,000 to $12,000 |
Tell every founder, investor and former colleague you know what you now do; this business is entirely referral at the start. Join the device accelerator and university spin-out communities in your region and offer a free one-hour regulatory assessment. Build your template library once (design controls, risk file, submission outline) so each project starts at 40 percent done.
At $200 an hour and 1,000 billable hours a year, a solo consultant grosses $200,000 with almost no overhead. Two or three fractional retainers at once is a steadier shape than project work. Growth means associates, and the margin on an associate’s hours is where a firm forms, but reputation is the only asset, so growth is slow by design.
No license to consult, but your work product is what the FDA reviews, and the client’s submission is signed by the client. Confidentiality and intellectual property terms in every contract. Your own conflict rules when two clients compete. Export rules if a client sells abroad.
A client who runs out of funding mid-submission and does not pay; bill monthly and stop work when they stop paying. An agency reviewer who disagrees with your strategy, which is why you never promise a clearance date. The feast-and-famine rhythm of project work. The consultants who last keep retainers, keep learning the guidance documents, and say no to clients with devices they do not understand.