Overview
This Integrated Management System equips medical-device manufacturers to design, produce, and place safe, compliant devices on regulated markets. It integrates ISO 13485, ISO 9001, ISO/IEC 17020, and ISO 31000 into a single quality and risk framework aligned with global regulatory expectations. The documentation governs the full device lifecycle: design and development controls, risk management, purchasing and supplier control, production and process validation, sterilization and cleanliness where relevant, traceability, and post-market surveillance including complaints and vigilance. A master Quality Manual sets device-quality policy and regulatory responsibilities, supported by procedures for CAPA, nonconforming product, change control, UDI and labeling, and management review. Validated forms and records maintain the device master record and technical-file evidence auditors and notified bodies require, while checklists translate ISO 13485 clauses into daily manufacturing discipline. Training modules build and evidence workforce competence, and the ISO 31000 layer embeds structured risk management throughout. This kit is ideal for manufacturers pursuing ISO 13485 certification, CE marking or equivalent market access, or supplier approval by larger OEMs. Every document is fully editable to your device types, processes, and facilities, removing the burden of building a technical quality system from scratch. By harmonizing quality, inspection, and risk requirements, it strengthens product safety, streamlines audits, and accelerates certification and market entry. The outcome is a manufacturing operation that consistently produces conforming devices, satisfies regulators and notified bodies, and continuously improves — protecting patients and securing your access to demanding markets.
Included: 65 ready-to-use, fully editable documents (manual, procedures, forms, records, checklists, guidance and training material).
License: single-organization license; delivered electronically as a ZIP archive.
From purchase to audit-ready
Buy & download instantly
Pay securely by card. Your ZIP download link appears immediately on the confirmation page and in your email.
Edit & brand as your own
Open the native Word & Excel files, add your logo and details, and adapt everything to your organisation.
Implement & get audit-ready
Roll out the manuals, procedures, forms and checklists to build a working, certification-ready system.
Frequently asked questions
What exactly do I receive?
A downloadable ZIP containing the full set of ready-to-use documents for this toolkit — manuals, procedures, forms, records, checklists, guidance and training material, all in editable Word and Excel format. The exact document count is shown at the top of this page.
Are the documents really editable?
Yes. Every file is native Microsoft Word or Excel — no locked PDFs. Add your logo, change wording, and tailor the content to your organisation. The toolkit is yours to keep and reuse.
Does this certify my organisation?
No. These are documentation toolkits aligned to the relevant standard to help you prepare. Certification itself is issued by an accredited certification body after their audit. Our toolkits give you a strong, audit-ready starting point.
How is it delivered?
Instantly and digitally. There's no physical shipment — you download the files right after payment and receive a backup link by email.
Do I get updates?
Yes. If we revise this toolkit, you're entitled to the updated version at no extra cost — just contact us with your order details.
What is your refund policy?
Because these are digital products delivered instantly, all sales are final once downloaded. If you have any issue with your files, contact us and we'll make it right. See our Refund Policy for full details.