ISO 14971 Course
Pilot cohort training covering hazard identification, risk evaluation, risk control, residual risk acceptability, and living risk file maintenance through post-market surveillance for medical device teams.
Build a living ISO 14971:2019 risk management capability for your medical device team, not just course completion. QMS Learning’s pilot cohort combines self-paced training, role-profile onboarding, AI Workbench support, manager dashboard visibility, and audit-evidence export so QMS managers and regulatory affairs professionals can identify hazards, control risk, and maintain defensible risk files through post-market surveillance.
Practical medical device risk management training supported by AI tools, dashboard visibility, and audit-ready evidence exports.
Pilot cohort training covering hazard identification, risk evaluation, risk control, residual risk acceptability, and living risk file maintenance through post-market surveillance for medical device teams.
A bundled pilot pathway connecting ISO 14971 with ISO 13485, FDA 21 CFR Part 820, and HIPAA obligations for medical device and life sciences compliance teams.
Clause-by-clause ISO 13485:2016 training covering design controls, document control, CAPA, management review, and internal audit responsibilities for regulated device manufacturers.
Training on the FDA Quality System Regulation, inspection readiness, Form 483 response, and QSIT approach for teams preparing for FDA-regulated medical device operations.
AI-powered compliance support trained on medical device standards, helping teams draft plans, build risk artifacts, generate CAPA records, and apply the right method.
Manager Dashboard visibility and Audit-Evidence Package exports help leaders document training, scenarios, generated artifacts, and time-stamped activity for audit-ready proof.
Your team starts with role-profile onboarding so QMS managers, regulatory affairs professionals, and other learners enter the pathway with relevant context, responsibilities, and platform access aligned to medical device risk management work.
Regulated teams use QMS Learning to turn training completion into practical audit-ready capability.
QMS Learning turns compliance training into usable, auditable team capability.
Built by a 20-year practitioner who has written and closed real audit findings.
Combines online training, AI problem-solving, dashboard visibility, and evidence management in one platform.
Audit-Evidence Package exports compile records, activities, and artifacts in minutes instead of days.
Self-paced delivery reduces scheduling friction while supporting team licensing and pilot cohort rollout.
Practitioner-built training led by real audit experience.
Founder
Will Trikha is the Founder of QMS Learning and a quality and operations practitioner with over 20 years of hands-on experience in regulated industries. Having written more than 1,000 findings as an auditor and closed twice that number as a quality manager, Will brings unmatched real-world depth to compliance training. His career has been built on the aerospace and defense audit floor, with deep expertise in AS9100D, ITAR, and related compliance frameworks. Frustrated by the persistent gap between conventional training and actual audit-ready capability, Will created QMS Learning to give quality teams the diagnostic judgment, AI-powered tools, and evidence management systems they need to walk into any audit with confidence. His practitioner-first philosophy shapes every course, pathway, and platform feature at QMS Learning.
The course is designed for medical device QMS managers and regulatory affairs professionals who need practical ISO 14971:2019 risk management capability. It is especially relevant for teams responsible for hazard identification, risk evaluation, risk control, residual risk acceptability, and maintaining a living risk file through post-market surveillance activities.
Talk with QMS Learning about pilot timing, pricing, and team rollout.
Built by a 20-year quality practitioner.
Evidence exports built for audit readiness.
AI support scoped to compliance methods.
Request a demo to review pilot availability, team licensing, platform features, and rollout fit for your medical device compliance team.
To help us assist you faster, please include the reason for your message so the relevant team can reach out as soon as possible.
To help us assist you faster, please include the reason for your message so the relevant team can reach out as soon as possible.