Toolkits & Templates
Establishing and maintaining compliance under the MDR, IVDR, and ISO 13485 requires extensive documentation, policies, procedures, records, and technical evidence that demonstrate conformity across every process and product. Developing this documentation from the ground up can consume significant time and resources, particularly for small and mid-sized organisations. Teams often reinvent the same materials, introduce inconsistencies, or overlook critical details required for regulatory approval. These inefficiencies delay certification and increase the risk of non-conformities. Structured, professionally developed documentation frameworks offer a proven means of accelerating compliance while maintaining rigor and consistency.
Our Toolkits and Templates provide organisations with regulator-aligned, fully customisable documentation suites covering all major areas of medical device and IVD compliance. Developed by experienced regulatory consultants and validated through numerous successful audits and Notified Body reviews, these materials reflect current European regulatory expectations and industry best practice. Each toolkit provides the foundation for rapid, consistent implementation while allowing full tailoring to the organisation’s processes and product lines.
Our library includes templates and SOP frameworks for:
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QMS procedures compliant with ISO 13485: document control, design and development, supplier management, CAPA, and internal audits.
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Annex II/III structure templates, GSPR matrices, clinical evaluation and performance evaluation report outlines, and risk management summaries aligned to ISO 14971.
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PMS plans, PSUR templates, PMCF reports, and vigilance reporting workflows.
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data models, submission trackers, and role-based process maps.
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Training matrices, records, and evaluation templates to evidence staff qualification.
Quality Management System procedures compliant with ISO 13485: document control, design and development, supplier management, CAPA, and internal audits.
MDR and IVDR Technical Documentation: Annex II/III structure templates, GSPR matrices, clinical evaluation and performance evaluation report outlines, and risk management summaries aligned to ISO 14971.
Post-Market Surveillance: PMS plans, PSUR templates, PMCF reports, and vigilance reporting workflows.
EUDAMED and UDI: data models, submission trackers, and role-based process maps.
Training and Competence: training matrices, records, and evaluation templates to evidence staff qualification.
Each document is designed to provide clarity, traceability, and audit-readiness. Built-in cross-references ensure consistency between procedures, records, and technical files. Clients can deploy the materials as complete systems or integrate individual components into existing documentation.
We also support clients in adapting these toolkits to their operational environment. Our consultants review process flows, align templates to business practices, and ensure that document interdependencies reflect actual workflows. This tailored approach results in systems that are both compliant and practical, minimising disruption while enhancing quality oversight.
Using standardised toolkits delivers measurable benefits: reduced documentation development time, faster certification preparation, and improved consistency across global operations. For organisations transitioning to MDR or IVDR, our materials provide a controlled pathway for upgrading documentation structures and closing identified gaps efficiently.
All toolkits are maintained under continuous review to reflect the latest regulatory developments and guidance from the European Commission, MDCG, and international standards bodies. Clients receive updated materials as part of their engagement, ensuring that documentation remains current and regulator aligned.
Our consultants ensure that every document, checklist, and form serve a defined purpose within the compliance framework. The result is documentation that enhances—not complicates—operations.
By deploying our Toolkits and Templates, organisations establish a structured, repeatable foundation for compliance that saves time, reduces errors, and strengthens regulatory confidence.
For further information or to obtain our customisable Toolkits and Templates for your organisation, please contact our regulatory systems and documentation team.
