Build a fully compliant Quality Management System — without starting from scratch.

The ISO 13485 QMS Complete Bundle gives you a ready-to-use, audit-ready documentation framework covering every core process required by ISO 13485:2016. Designed for medical device manufacturers, regulatory consultants, and startups building their QMS for the first time — or companies looking to standardize and strengthen an existing system.

PRODUCT HIGHLIGHTS

• 70+ editable documents
• 22 QMS processes covered
• Format: Word + Excel (fully editable)
• Standard: ISO 13485:2016
• Last updated: April 2025
• Language: English
• Instant download after purchase

What’s included?

 Governance & Planning Management review procedure and meeting templates, KPI and data analysis framework, QMS risk analysis template.

Risk & Design Control Risk management procedure, plan, report, hazard analysis, and traceability matrix. Full design control package including D&D plan, design inputs, verification plan, design review, DHF and DMR index templates, and biological risk assessment.

Audit & CAPA Complete internal audit management system — annual plan, audit plan, audit report — plus a fully structured CAPA process with procedure, template, and tracking database.

Supplier & Purchasing Supplier management procedure, initial evaluation, ongoing monitoring, supplier list, and purchase management with purchase order template.

Post-Market & Vigilance Post-market surveillance procedure, PMS plan, PMS report, PSUR template, EU vigilance reporting procedure, and field actions/advisory notices procedure.

Operations & Manufacturing Production and service provision, incoming control, process validation, sterilization validation (ionizing radiation), infrastructure and equipment management, control of equipment.

Document & Change Control Document control procedure, change control with notified body notification procedure, change control template and tracking database.

Complaint & Feedback Management Complaint handling procedure and template, customer complaints database, customer feedback database.

Supporting Processes HR and training management, computer system validation, usability procedure and file template, UDI management procedure, clinical evaluation procedure and investigator brochure template, medical device file procedure, customer-related process procedure.

Who is this for?

• Startups building their QMS ahead of their first ISO 13485 certification audit
• PMI manufacturers preparing for surveillance or recertification
• Regulatory consultants who need a reliable, customizable document baseline for client projects
• Companies expanding internationally requiring QMS alignment with EU MDR, MDSAP, or FDA QSR

Why this bundle?

All documents are written by regulatory affairs professionals with direct audit experience. They follow the structure auditors expect — reducing the risk of non-conformities at your next audit and saving you weeks of documentation work. Every template is immediately editable and includes clear guidance on what to fill in each section.

Frequently asked questions

Are these documents editable? Yes. All documents are delivered in Microsoft Word and Excel format. You can fully customize them to reflect your organization’s name, scope, processes, and product portfolio.

Are these templates compliant with the latest version of ISO 13485? Yes. All documents are aligned to ISO 13485:2016, the current version of the standard, and are regularly reviewed to reflect guidance updates.

Can I use these templates for multiple products or projects? Yes. Once purchased, you can use the templates across your organization and for multiple product lines. The license covers internal use within a single legal entity.

Do these templates also cover EU MDR requirements? Several processes in this bundle — including post-market surveillance, vigilance, clinical evaluation, UDI, and design control — are also relevant to EU MDR compliance. For full MDR technical documentation coverage, see our EU MDR Compliance Kit.

What format are the files delivered in? Word (.docx) for procedures and report templates, Excel (.xlsx) for databases, trackers, and planning templates. A PDF overview is also included.

How are the documents delivered? Instantly after purchase via a secure download link sent to your email.