ISO 13485 Complaint Handling, PMS & Vigilance Kit
ISO 13485 Complaint Handling, PMS & Vigilance Kit
Regular price
$99.00 USD
Regular price
Sale price
$99.00 USD
Instant download. Editable files. One-organization licence. 5-day fit guarantee.
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This kit is one of 15 in the ISO 13485 Complete QMS Kit: every kit for $449 instead of $1,375 bought separately.
See the ISO 13485 Complete QMS KitNot ready to buy? Get free sample pages from this kit
5-day fit guarantee. If it does not fit your QMS, ask for a refund within 5 days. Conditions.
From the first customer call to a regulator report: complaint handling, reportability decisions for FDA and EU MDR, post-market surveillance, field safety corrective actions and advisory notices, plus a worked example that links a complaint to CAPA and the risk file.
What's inside (29 files)
- Complaint Handling: Complaint Trend Sheet; Complaint and Feedback Form; Complaint and Feedback Handling SOP.
- Regulatory Reporting: Regulatory Reporting SOP - Generic; Regulatory Reporting SOP - US FDA (MDR); Vigilance Reporting SOP - EU MDR.
- Post-Market Surveillance: PMS Data Sources and Signal Review; PMS Plan; PMS Report; Post-Market Surveillance Procedure.
- Field Actions and Advisory Notices: Advisory Notice - EU MDR; Advisory Notice - ISO 13485; FSCA Customer Response Form; Field Action Notice - US FDA; Field Safety Corrective Action SOP; Field Safety Notice.
- Complaint to CAPA to Risk Worked Example: Complaint to CAPA to Risk - Filled Example; Complaint to CAPA to Risk - Operating Manual; Complaint to CAPA to Risk - Record Templates; Complaint to CAPA to Risk - Tools Workbook.
- Training: Complaint Handling training module (slides, trainer guide, workbook, assessment); PMS and Vigilance training module (slides, trainer guide, workbook, assessment).
How to use it
- Adapt the complaint SOP and form; decide who evaluates complaints and how fast.
- Choose the reporting SOP for your markets (US FDA MDR, EU MDR or generic) and set reportability decision rules.
- Write the PMS plan and feed complaint trends and other data into it.
- Keep the FSCA SOP and notice templates ready so an advisory notice can be issued at any time.
- Walk through the worked example to see one complaint flow into CAPA and a risk file update.
Who it's for
Manufacturers, importers and distributors who handle complaints, reportable events and field actions.
Good to know
- Instant download. Editable Microsoft Office files, no macros.
- Includes a Start Here guide with the contents and how to use them.
- Licensed for one organization, including its sites.
- Templates don't reproduce ISO standards. You need your own licensed copies.
- Also in the ISO 13485 Complete QMS Kit, which costs less than buying kits separately.
What every download includes
Instant downloadLink on the confirmation page and by email within minutes.
Fully editableWord, Excel and PDF. No macros. Works in Microsoft 365 and Google Workspace.
5-day fit guaranteeIf the files do not fit your QMS, ask for a refund within 5 days. Conditions apply.
Free updatesRevised files for this edition of the standard are sent to you at no charge. One-organization licence.
Templates refer to clause numbers and describe requirements in our own words. They do not reproduce the text of any ISO standard, so you need your own licensed copy. Templates support your system; they do not guarantee certification.
Questions about ISO 13485 Complaint Handling, PMS & Vigilance Kit
How will I receive the files?
A download button appears on the order confirmation page and the same link is emailed to you within a few minutes. Bundles arrive as one ZIP file.
Can I get a refund?
Yes. With our 5-day fit guarantee, if the files do not fit your quality management system you can ask for a full refund within 5 days of your order. It applies once per customer and organization, covers the whole product, and requires you to confirm you have deleted the files. We also refund non-delivery, defective files, wrong items and duplicate purchases within 30 days. Read the full refund policy.
Can I see the files before I buy?
Yes. The images above show real pages from the files, and most kits have free sample pages you can download with your email address.
Can I use the templates with more than one company?
Each purchase is licensed to one organization. Consultants and groups need one licence per client or legal entity. See the licence agreement.
Also transitioning to ISO 9001:2026?
Many medical device manufacturers hold both certifications. If your quality system needs to cover the 2026 update to ISO 9001 as well as ISO 13485, these cover the same ground for the base standard.
