MEGACERT Academy
Regulatory Training & Workshops
Build in-house competency. Online live, on-site at your facility, or hybrid.
EU MDR 2017/745 Fundamentals
Full-day introduction to MDR scope, classification, GSPRs and notified body process.
8 hours Group or 1:1
ISO 13485:2016 Internal Auditor
ISO 19011-based internal auditor certification with case studies and audit simulations.
16 hours Group or 1:1
ISO 14971:2019 Risk Management
Risk analysis, FMEA, benefit-risk and ISO/TR 24971 guidance in practice.
8 hours Group or 1:1
Clinical Evaluation (MEDDEV 2.7.1 Rev 4 / MDCG 2020-1)
Writing a defensible CER — literature search, appraisal, gap analysis and PMCF link.
12 hours Group or 1:1
PMS & PMCF Workshop
Build a working PMS Plan, PSUR and PMCF Plan from your own device data.
8 hours Group or 1:1
FDA 510(k) Masterclass
Predicate device strategy, eSTAR walkthrough and Pre-Sub best practices.
8 hours Group or 1:1
Need a custom curriculum?
We design bespoke training for your team — from R&D engineers to Quality, RA and senior management.
Request a training proposal