For Medical Device Manufacturers
ISO 13485 Training & Document Control — Without the Enterprise Price Tag
ISO 13485 requires documented competency, controlled procedures, and complete training records. Training Tiger gives you all of it — set up in days, not months.
30-day free trial • No credit card required
ISO 13485 Has Zero Tolerance for Training Gaps
FDA 21 CFR Part 820 and ISO 13485 both require training records as documented evidence. This isn't a nice-to-have — it's a regulatory requirement that notified body auditors and FDA inspectors check as a matter of course.
"Personnel performing work affecting product quality shall be competent" — and that competency must be documented. Not assumed. Not verbal. Documented.
Notified body auditors and FDA inspectors will ask for training records on every audit. Missing or incomplete records don't just mean a nonconformance — they can mean potential market action.
Missing or incomplete training records = nonconformance = potential market action. The stakes in medical devices are higher than in any other industry.
Everything ISO 13485 Section 6.2 Requires
Every requirement in Section 6.2 maps directly to a Training Tiger feature.
Determine Necessary Competence
Use the skills matrix to define what competence is needed for each role. See gaps at a glance.
Provide Training
Assign controlled documents and training materials to roles and individuals. Track completion from your dashboard.
Evaluate Effectiveness
AI-generated quizzes or manager sign-off verify that employees understood the material — not just that they opened it.
Maintain Records
Complete audit trail with timestamps, document versions, quiz scores, and sign-off records. Export for auditors in one click.
Controlled Documents, Every Revision
ISO 13485 Section 4.2.4 requires control of documents. Every procedure, work instruction, and form must be version controlled, approved, and accessible to the people who need them.
Training Tiger gives you controlled documents with full version history and approval workflows. When a document is revised, affected employees are automatically re-assigned training on the new revision.
No more chasing people down to confirm they've seen the latest version. No more wondering if the operator on third shift is running revision 2 or revision 5.
Who It's For
Small & Mid-Size Medical Device Manufacturers
Class I and Class II device manufacturers who need ISO 13485 compliance without the enterprise price tag.
Contract Manufacturers
Serving medical device OEMs and need to demonstrate compliant training and document control to your customers.
Start your free trial today — no credit card required
Get your ISO 13485 training and document control system set up in days, not months.
Start Your Free Trial30 days free • No credit card required