Company intelligence
MEDIcept Inc.
Global Medtech Clinical, Regulatory, Reimbursement, Compliance & Quality Consultancy
About MEDIcept Inc.
Medicept is your trusted integrated lifecycle partner bringing global expertise in regulatory, quality, clinical, and commercialization together in one team. Our experts reduce risk, eliminate costly gaps, and keep critical programs moving forward. Move ahead with confidence knowing every decision is aligned across the product lifecycle, helping you achieve key milestones and bring innovations to patients faster.
Verified activity
Signals from MEDIcept Inc.
6 published signals
Presence & Recognition
MEDIcept Inc. is hosting a class on new FDA inspection methods from 1st hand experience in Minneapolis at MD&M on October 28th.
Reported by F. David Rothkopf
Presence & Recognition
MEDIcept Inc. is attending RAPS Convergence 2026 in Charlotte from September 15 to 17 to discuss regulatory, quality, and clinical topics.
Reported by MEDIcept Inc.
Legal & Regulatory
MEDIcept Inc. noted that risk management now tops the list of observation categories.
Reported by MEDIcept Inc.
Legal & Regulatory
MEDIcept Inc. noted that nearly 90% of post-QMSR Form 483 observations cite incorporated ISO 13485:2016 clauses directly.
Reported by MEDIcept Inc.
Legal & Regulatory
MEDIcept Inc. noted that FDA also has explicit authority to inspect records that used to be off-limits, including management review minutes, internal audits, supplier files, and even legacy QMS documentation.
Reported by MEDIcept Inc.
Legal & Regulatory
MEDIcept Inc. highlighted that the Director of Regulatory Affairs, Melissa D., and Manager of Quality Systems, Ryan Satterly, break down what's actually showing up in inspections right now, and what it takes to show a defensible, risk-based rationale behind every quality decision.
Reported by MEDIcept Inc.