Regulatory Studio was founded by a regulatory affairs professional with hands-on experience in EU MDR transition and certification and ISO 13485 quality management systems. Before moving into regulatory affairs, I worked as a laboratory analyst in the pharmaceutical and medical device industries. With a Bachelor of Science and an MBA, I understand both the technical side of compliance and the business constraints small teams face.

I built these tools because I kept seeing the same problem: small medtech teams and solo founders facing the same regulatory requirements as large manufacturers, without the budget for $2,000–10,000 consulting engagements.

Every workbook and guide here comes from real regulatory work, not generic templates. They're built to help you understand what's required, organize your evidence, and walk into your certification or audit prepared.

Regulatory Studio's tools support your regulatory work but do not replace professional regulatory or legal advice for your specific device.