Regulation

Get clear, actionable steps for biocompatibility ISO 10993. Learn how to assess medical device safety, testing requirements, and compliance essentials.

Learn what a cosmetics responsible person is under MoCRA, their key duties, and how to keep your beauty brand compliant with FDA regulations.

Get a clear, step-by-step guide to building a usability engineering file for medical devices, with practical tips for compliance and user safety.

Get practical steps for 21 CFR Part 11 compliance. Learn how to secure electronic records, manage e-signatures, and meet FDA requirements with confidence.

Get clear, step-by-step advice on food facility registration FDA requirements, including who must register, exemptions, and tips for staying compliant.

Get a clear overview of drug device combination products, including definitions, FDA regulations, compliance tips, and key steps for successful development.

Get a clear overview of the ISO 13485 lead auditor course, including requirements, benefits, training formats, and tips for choosing the right provider.

Get a clear, step-by-step guide to the breakthrough devices program, including eligibility, benefits, and tips for a successful FDA application.

Get a clear, practical overview of chemistry manufacturing and controls CMC, including key steps, documentation tips, and compliance essentials.

Get clear answers on what an IDE application is, why it matters in MedTech, and how to prepare a strong submission for FDA approval.