Medical device QA, validation & regulatory teams
Train your team to the standards your next audit will check.
Three courses on ISO 14971, IEC 62304, and IEC 62366-1 — the consensus standards FDA and EU notified bodies expect — delivered to your whole team in one enrollment.
3 courses · 169 lessons · save $785 vs. buying separately
QA and regulatory teams at these companies train with Nopmark
Three courses, one enrollment
The bundle covers the three consensus standards FDA and EU notified bodies expect medical device teams to work to — taught end to end, from each standard’s intent to implementation.
ISO 14971
Risk management across the product lifecycle
IEC 62304
Medical device software lifecycle processes
IEC 62366-1
Usability & human factors engineering
169 lessons across all three courses. Bought separately: $1,785. Bundle: $1,000 (90-day) or $1,100 (1-year) — you save $785.
Preview the training before you enroll
The first module of each course is free to preview, so you can see exactly how we teach ISO 14971, IEC 62304, and IEC 62366-1 before you pay. Your access includes updates as the standards and FDA / notified-body expectations evolve, and the same team behind our ISTQB Free Pass Guarantee stands behind every course here.
Learn from a practitioner, not a slide deck
These courses are written and maintained by people who have sat on the manufacturer's side of an audit.
Niranjan Maharajh
25 years in product development & testing · 20+ years in medical devices · Instructor, UC Santa Cruz Medical Device Quality & Design Certificate Program
Niranjan has spent 25 years in product development and testing — more than 20 in medical devices — across software QA, test automation, design verification & validation, and quality system management at Medtronic, Johnson & Johnson, and Carl Zeiss Meditec. He also taught at UC Santa Cruz’s Medical Device Quality & Design Certificate Program, and writes these courses from the manufacturer’s side of the audit table.
Questions regulatory teams ask us
Short answers below. Anything else, contact us and a person will reply.
Does this training align with FDA and notified-body expectations?
The three courses teach ISO 14971 (risk management), IEC 62304 (software lifecycle), and IEC 62366-1 (usability engineering), the consensus standards FDA and EU notified bodies recognize for these topics. Training your team on them supports, but does not by itself constitute, your quality system compliance.
Do I get a certificate?
Yes, you receive a certificate of completion for each of the three courses, suitable for your training records. These are Nopmark certificates, not ISTQB certifications.
Who is the bundle for?
QA engineers, software validation engineers, RA/QA specialists, and engineering leads at medical device companies, plus anyone moving into medical device work from general software QA.
How long do I have access?
Two options: 90-day access at $1,000 or 1-year access at $1,100. Both include all three courses (169 lessons total). Buying them separately costs $1,785, so the bundle saves $785.
Can I train my whole team?
Yes. We support group discounts, purchase orders, and invoicing for teams of 5 or more, and can scope private workshops on risk management and audit readiness. Request a team quote and we respond within one business day.
Do I need prior medical device experience?
No. Each course starts from the standard's intent and builds to implementation detail. Experienced practitioners can move quickly through the fundamentals; newcomers get the context they need.
Ready for your next audit to be uneventful?
All three courses, one enrollment. Start today and train at your own pace.
Teams of 5+: group discounts, purchase orders, and invoicing available.