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. 30-day money-back guarantee.
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- Best for
- Manufacturers that must handle complaints, report to FDA or EU authorities and run post-market surveillance under clauses 8.2.1, 8.2.2 and 8.2.3.
- What it gets done
- Complaint SOP and form, trending, FDA and EU vigilance SOPs, PMS procedure, plan and report, FSCA SOP and notices, two training modules.
- What you still do
- Adopt the complaint form, set reporting decision rules for your markets, write the PMS plan for each device and start trending.
- See it first
- Free sample pages.
One-organization licence · Free updates for this edition · Email support· Purchase terms
- 30-day money-back guarantee. If it does not fit your QMS, email us within 30 days for a full refund. Conditions.
- Know what you are buying. The images above are real, unedited pages from the download, and a free sample is a few lines down.
- Secure checkout, instant access. Card, PayPal, Apple Pay, Google Pay or Shop Pay. Your download link is emailed to you within minutes of checkout, and you can re-download from your order confirmation at any time. Sold by ISO Cloud Consulting LLC, USA.
- Ask the author before you buy. Email a question and the person who wrote the files replies within 2 business days.
Upgrade and save
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 KitOptional add-ons, training and free samples
Upgrade credit if you buy a bigger kit later
- If you move up to the ISO 13485 Starter Kit or Complete QMS Kit later: code
STARTER-UPGRADE, a fixed $79 off.
Credits are fixed amounts. Where the credit equals the price of what you own, you pay only the difference; otherwise the credit is the amount shown. Use the same email address as your first order; one credit per order and per customer, not combinable with other discounts.
ISO consultant? Use this template with up to 10 clients, with your own or your client's branding: consultant edition.
Train your team on this
Make sure the whole team understands the requirement behind these records. The ISO 13485 Foundations Course is online and self-paced.
ISO 13485:2016 Foundations Course (Online, Self-Paced, Certificate of Completion), $99Certificate of Completion issued by ISO Cloud Consulting. It is not an accredited or third-party qualification.
Also see: ISO 13485:2016 Lead Implementer Course (Online, Certificate of Completion), $399. Browse the Academy.
Want to learn how to implement ISO 13485 with these templates? ISO 13485:2016 Lead Implementer Course (Online, Certificate of Completion): online, unlimited access, certificate of completion.
Not ready to buy? Get free sample pages from this kit
Before you buy
- Who wrote it: Ishan Maharaj, an industrial engineer (BSc Eng Hons, MSc Engineering Management) who builds and runs certified ISO 9001 and ISO 13485 quality systems. See the ISO 9001 and ISO 13485 case studies.
- Buying for a company? Need a quote or invoice for a purchase order first? Email hello@isocloudconsulting.com and we will send one.
- Not sure it fits? Email the same address with your company size and scope, and get a straight answer from the person who wrote the files.
Complaints are the first records an FDA investigator or notified body pulls, and the QMSR now mandates seven data elements in every complaint record. This kit gives you complaint handling, regulatory reporting for the US and EU, a post-market surveillance plan and report, field action procedures and notices, a worked example that follows one complaint through CAPA to a risk file update, and two training modules.
What's inside (30 files: 23 Word, 4 Excel, 2 slide decks, 1 PDF)
- Complaint handling (3): Complaint and Feedback Handling SOP; Complaint and Feedback Form; Complaint Trend Sheet.
- Regulatory reporting (3): Regulatory Reporting SOP (US FDA MDR); Vigilance Reporting SOP (EU MDR); generic version for other markets.
- Post-market surveillance (4): Post-Market Surveillance Procedure; PMS Plan template with data sources, indicators and thresholds; PMS Report; PMS Data Sources and Signal Review workbook.
- Field actions and advisory notices (6): Field Safety Corrective Action SOP; Field Safety Notice; FSCA Customer Response Form; Advisory Notice (ISO 13485 and EU MDR versions); Field Action Notice (US FDA).
- Worked example (4): Complaint to CAPA to Risk filled example, operating manual, record templates and tools workbook.
- Training (2 modules, 8 files): Complaint Handling and PMS and Vigilance, each with slides, learner workbook, assessment pack and trainer guide.
- Start Here guide and the November 2026 edition note.
How to use it
- Adopt the complaint form; check it against the QMSR 820.35(a) elements (the FDA QMSR Transition Kit carries the fully compliant version).
- Set numeric thresholds in the PMS plan.
- Decide reportability with the SOP for your market and record the decision.
- Trend quarterly and feed the risk file.
Who it's for
Manufacturers selling in the US or EU, distributors who handle complaints for a principal, and companies writing a first PMS plan. Need a PSUR? It is in the EU MDR Technical Documentation & GSPR Kit.
Good to know
- Instant download. Editable Word, Excel and PowerPoint, no macros. Licensed for one organisation including its sites; consultants can add the multi-client licence.
- November 2026 edition: every file cites ISO 14971:2019 and the FDA QMSR (21 CFR Part 820 as amended, effective 2 February 2026); role titles are market-neutral; a "What changed" note is in the download.
- Templates describe requirements in our own words and do not reproduce ISO text; you need your own copy of ISO 13485:2016.
- Also included in the ISO 13485 Complete QMS Kit.
- 30-day money-back guarantee if it does not fit your QMS.
Watch: how this works in practice
Watch: Once a device is on the market, the quality system has to listen. ISO 13485 from zero, episode seven: complaints, vigilance and post-market surveillance.
ISO 13485 Complaint Handling, PMS & Vigilance Kit$9930-day money-back guarantee
Three ways to buy ISO 13485 templates
Start with the gap assessment, build the core system with the Starter Kit, or get every kit at once. Upgrade credits mean you never pay twice for the same kit.
| What is included | Gap Assessment Workbook See where you stand before you commit $49View Gap Assessment Workbook | Starter Kit
Core system: 6 kits for clauses 4 to 6 and 8
$249 | Best valueComplete QMS Kit
All 15 kits, including design, risk and production
$449 |
|---|---|---|---|
| Gap assessment, 71 requirement areas with action plan | Included | Included | Included |
| Quality manual and management review kit | Not included | Included | Included |
| Document control and records kit | Not included | Included | Included |
| CAPA and nonconformance kit | Not included | Included | Included |
| Internal audit kit | Not included | Included | Included |
| Training and competence kit (8 modules) | Not included | Included | Included |
| Design controls and DHF kit, ISO 14971 risk management file kit | Not included | Not included | Included |
| Supplier control, production and traceability, equipment and calibration kits | Not included | Not included | Included |
| Software validation, medical device file and labelling kits | Not included | Not included | Included |
| Complaint handling, PMS and vigilance kit, plus the process validation IQ/OQ/PQ pack | Not included | Not included | Included |
| Start-here roadmap to certification | Not included | Not included | Included |
| Optional 60-minute onboarding call with the author | Not included | Included | Included |
| 30-day money-back guarantee, instant download, one-organization licence, free updates for this edition | Included | Included | Included |
Prices in USD. Crossed-out prices are the combined price of the included items bought separately. Own a smaller kit already? Upgrade credits are listed on each product page. Still unsure? Which kit is right for me?
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.
30-day money-back guaranteeIf the files do not fit your QMS, ask for a full refund within 30 days. Conditions apply.
Free updatesRevised files for this edition of the standard are sent to you at no charge. We email you the new files. Version history.
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. Licence, updates and refunds in one place: purchase terms. Sold by ISO Cloud Consulting LLC.
Questions about ISO 13485 Complaint Handling, PMS & Vigilance Kit
What does the complaint handling and PMS kit include?
Complaint and feedback handling SOP and form, complaint trend sheet, regulatory reporting SOPs for FDA MDR and EU MDR vigilance, post-market surveillance procedure, PMS plan and PMS report templates, field safety corrective action SOP and notices, two training modules and a complaint-to-CAPA-to-risk worked example. 30 files.
Does the complaint form meet the FDA QMSR?
Yes. The complaint record carries all seven data elements required by 820.35, including the justification when no investigation is performed.
Does it include a PMS plan template for EU MDR?
Yes. The PMS plan and PMS report templates follow Article 84 and Annex III. The PSUR template is in the EU MDR Technical Documentation and GSPR Kit.
Is this current for ISO 13485:2016 and the FDA QMSR?
Yes. ISO 13485:2016 is the current edition (confirmed by ISO in 2026) and the kit was revised in November 2026 for the FDA Quality Management System Regulation (21 CFR Part 820, in force since 2 February 2026) and EU MDR 2017/745. Revised files for this edition are sent to existing buyers free.
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 30-day money-back guarantee, if the files do not fit your quality management system you can ask for a full refund within 30 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. You can also see a fully worked example of a procedure and its linked records.
Will I get updates?
Yes, for the edition of the standard this product covers. Corrections, amendments and guidance changes for that edition are sent to you free, by email, for as long as we sell the product. If the standard is replaced by a new edition, the new kit is a separate product and existing buyers get an upgrade discount. See the version history.
Can I use the templates with more than one company?
Each purchase is licensed to one organization (one legal entity). Consultants can use one product with up to 10 client organizations with the Consultant Multi-Client Licence, including applying their own or the client's branding. See consultant rights and the licence agreement.
Who wrote these templates
Ishan Maharaj
Founder and Principal Consultant
BSc Engineering (Industrial) Honours and MSc Engineering Management
An industrial engineer who has worked in regulated medical device manufacturing throughout his career, in senior operations and quality leadership roles since 2019. Every template on this site was written and checked by him against the published standard, and the same person answers your questions.
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.
