Guidance, Analysis & Regulatory Insight
Practical publications for medical device and IVD regulatory affairs and quality professionals.
Postmarket Surveillance Guideline
A practical lifecycle reference for medical device and IVD regulatory and quality professionals.
Connect complaint handling, vigilance and MDR assessment, signal evaluation, CAPA, field action decisions, and risk-management feedback into one coherent postmarket system.
All Publications
Guidelines, white papers, regulatory insights, and technical articles.
Using AI to Strengthen Risk Management in ISO 13485 and ISO 14971 Environments
This white paper explores how AI can support ISO 13485 and ISO 14971 risk management activities while maintaining appropriate human oversight, traceability, and quality system controls.
Preparing for Audits and Regulatory Inspections
Inspection readiness starts long before an auditor arrives. Preparation, documentation, training, and response planning can reduce risk and improve outcomes.
Navigating Regulatory Affairs for IVD and Medical Devices
Understanding Regulatory Affairs Regulatory affairs play a vital role in the medical device and in vitro diagnostics (IVD) industries. Companies in this space must navigate complex regulations in different regions to ensure…
Navigating Regulatory Affairs in Medical Device Consulting
Understanding Regulatory Affairs in the Medical Device Sector In the ever-evolving landscape of medical device and in vitro diagnostic (IVD) companies, regulatory affairs and quality assurance are critical components that define success.…