ISO 13485 Design Controls & DHF Kit
ISO 13485 Design Controls & DHF Kit
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Instant download. Editable files. One-organization licence. 30-day money-back guarantee.
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- Best for
- Companies that design or change devices and need ISO 13485 clause 7.3 design controls (and the equivalent FDA expectations).
- What it gets done
- Design and development plan, inputs and outputs matrices, design reviews, V&V traceability, transfer and design change records, plus a design file index.
- What you still do
- Run your project through the plan, hold and record the reviews, execute verification and validation, and keep the traceability matrix current.
- See it first
- Free DHF audit checklist.
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
Implementing ISO 13485 takes more than documents. The Lead Implementer Course shows how to set up, run and maintain the QMS these templates support.
ISO 13485:2016 Lead Implementer Course (Online, Certificate of Completion), $399Certificate of Completion issued by ISO Cloud Consulting. It is not an accredited or third-party qualification.
Also see: ISO 13485:2016 Complete Training Track (3 Courses, 3 Certificates of Completion), $599. 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.
Design controls are where device start-ups fail Stage 2 and where FDA cites clause 7.3.9 change control. This kit is an execution system, not a set of blank forms: the procedure, the plan, specifications and matrices for inputs and outputs, review, verification, validation and transfer packs, change control, the risk linkage to ISO 14971, the DHF index, a filled worked example and an audit-defence pack that lists the traps auditors set.
What's inside (39 files: 21 Word, 12 Excel, 1 slide deck, 5 PDF)
- Execution system (18): Design Controls Guide and SOP; Master Registers; Design and Development Plan and Plan Tracker; Design Inputs Specification and Matrices; Design Outputs Specification and Matrices; Design Review Pack and Action Log; Verification Pack; Validation Pack; Verification and Validation Matrix; Design Transfer Pack; Design Change Control Pack and Transfer and Change Trackers; Risk Management Linkage Pack and Risk Traceability Matrix.
- Additional templates (8): DHF Index; DHF Audit Checklist; Feasibility and Concept Assessment; Usability and Human Factors Evaluation Record; Software Development Lifecycle Plan; Clinical Evaluation Report template; Regulatory Submission Cross-Reference (FDA QMSR, EU MDR, UK, Canada); Lessons Learned Review.
- Worked example and audit defence (8): filled records and registers for a fictional device, an operating manual, blank workbook, evidence index with a traceability closure test, audit failure patterns with test scripts, and "Design Controls Audit Traps and Defences".
- Training (1 module, 4 files): Design Control slide deck (15 slides), learner workbook, assessment pack and trainer guide.
- Start Here guide (PDF).
How to use it
- Adopt the SOP and open the plan at project kick-off.
- Write inputs and outputs in the specifications; the matrices give you traceability for free.
- Hold reviews at the gates in the plan; log actions.
- Close verification and validation in the V&V matrix, transfer, and file the DHF index.
Who it's for
Start-ups taking a first device through development, manufacturers remediating a thin design history file, and consultants running design control under ISO 13485, the FDA QMSR and EU MDR.
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: Design controls are where the device's safety and performance are decided, and where the design history file is built. ISO 13485 from zero, episode four: design controls in the order they happen.
Watch: Design transfer is the step where a medical device stops being an engineering project and becomes a product you can make, again and again, the same way. Design transfer: where device start-ups lose six months.
ISO 13485 Design Controls & DHF Kit$14930-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 Design Controls & DHF Kit
What does the design controls kit cover?
All of clause 7.3: design and development SOP, project plan, inputs and outputs matrices, design review records, verification and validation plans and reports, design transfer checklist, design change control and a design history file index. 39 files including a worked example and training module.
Does it work for FDA design controls (820.30)?
Yes. Under the QMSR, design controls are assessed through ISO 13485 clause 7.3. The DHF index maps to the FDA design history file and the templates keep the terminology both auditors recognise.
Does it include a traceability matrix?
Yes. The requirements-to-verification traceability matrix links user needs, design inputs, outputs, verification and validation and risk controls.
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.
