For quality leaders at medical device manufacturers and contract manufacturers. Train your team on ISO 13485, FDA 21 CFR Part 820, ISO 14971 risk management, and HIPAA. Manager dashboard. Audit-Evidence Package PDF. AI Workbench that knows medical device.
Quality directors, regulatory affairs managers, and design assurance leads at medical device manufacturers, contract manufacturers, IVD companies, and combination product developers.
An untrained team produces inconsistent documentation. Investigators notice. The 483 becomes a Warning Letter. Your customers find out within hours.
Notified bodies don't grade on a curve. A team that's read the standard but never practiced the workflows fails the practical questions.
Risk management isn't a one-time document. If your team can't show living risk files tied to design changes and post-market data, you fail.
21 CFR 820.30 isn't a paperwork exercise. Teams that learned design controls from a textbook miss the link between user needs, design inputs, and verification.
After 30 days of rollout, here's what changes.
Every course includes role-profile onboarding, AI Workbench access, Manager Dashboard visibility, and Audit-Evidence Package export.
Every clause of ISO 13485:2016. Design controls, document control, CAPA, management review, internal audit. Built for medical device QMS managers and regulatory affairs.
Quality System Regulation. Subpart-by-subpart deep dive. Inspection readiness. Form 483 response. The Quality System Inspection Technique (QSIT) approach.
Hazard identification, risk evaluation, risk control, residual risk acceptability. Living risk file maintenance through post-market surveillance.
Privacy Rule, Security Rule, breach notification, BAA obligations. For medical device makers handling PHI through connected devices, software, or integrations.
Trained on ISO 13485:2016, FDA 21 CFR Part 820, ISO 14971:2019, ISO 14971:2020 amendment, and FDA Quality System Inspection Technique. Draft design history file entries. Build risk management plans. Generate CAPA records. The AI compliance partner that knows medical device.
Walks the team through the 10 most common compliance plays — root cause, CAPA, internal audit prep, supplier qualification, change control, deviation. Right method for the right problem.
SOPs, audit checklists, gap analyses, nonconformity reports — generated in your standard's voice, tailored to your facility, ready to put in front of an auditor.
See who's completed what, where capability gaps are, and which standards each team member is fluent in. The visibility a quality leader actually needs.
Single PDF export. Training records, completed scenarios, generated documents, time-stamped Workbench interactions. Hand it to the registrar. They accept it.
The root cause and corrective action training transformed how our team approaches problem-solving. We now have a structured, disciplined process across our operations.
The AS9100D training exceeded our expectations. The professionalism and depth of knowledge is outstanding. They have exceeded our expectations for over 3 years.
Our team is now confident in identifying hazards, conducting risk assessments, and maintaining compliance. The interactive approach made complex regulations easy to understand and apply on the shop floor.
Free 14-day pilot. 2 seats. Full Workbench access. No credit card required. If the fit isn't there, walk away — no calls, no follow-up, no obligation.
Book a demo to start your pilot30-minute working demo. We'll scope this pathway to your team's standards and audit timeline. You'll see the Workbench, the Manager Dashboard, and the Audit-Evidence Package on the call.
Book a 30-min demoDemos run Tuesday, Wednesday, Thursday • 10am–4pm PST