PMS & Vigilance Training Kit

Training records alone do not prove competence; most teams struggle to give consistent, auditable instruction on post-market surveillance and vigilance and then verify that people actually understood the process. This training kit gives you a ready-to-run module for post-market surveillance and vigilance, including facilitator material, learner content, and evidence of training effectiveness you can file in the QMS. It is built to help teams understand the process properly, not just complete a training record.

What's included

• PMS & Vigilance Training Kit Slide Deck.pptx
• PMS & Vigilance Training Kit Learner Workbook.docx
• PMS & Vigilance Training Kit Assessment Pack.docx
• PMS & Vigilance Training Kit Trainer Guide.docx

Best suited to: Quality team, Process owner, Trainer, and New employee.

Useful in audit situations where you need to:

• Show a structured post-market surveillance and vigilance training process during ISO 13485 certification, surveillance, supplier, or internal audits.
• Support FDA inspections with controlled records, traceability, and process evidence related to post-market surveillance and vigilance training.
• Support EU MDR technical documentation or quality-system reviews where post-market surveillance and vigilance training records need to be complete, controlled, and consistent.

It gives you a faster way to roll out consistent instruction, show training effectiveness, and close the gap between the written procedure and how the team actually performs the work.