Resources
Guides for MDR technical documentation and quality work
Answer-first guides written for regulatory affairs and quality teams. Each guide states which regulation or standard it applies to, cites the primary source, and explains where software helps and where qualified judgement is still required.
MDR
The regulation, its annexes and the technical documentation it requires.
- What Is EU MDR 2017/745?A plain explanation of the EU Medical Device Regulation 2017/745: scope, key dates, classification, conformity assessment, economic operators and what changed from the MDD.Read the guide
- EU MDR Technical Documentation: Complete GuideWhat EU MDR technical documentation is, who reviews it, how long to keep it, how it connects to the QMS and how to keep it current over the device lifecycle.Read the guide
- MDR Annex II and Annex III ExplainedSection-by-section explanation of MDR Annex II (technical documentation) and Annex III (technical documentation on post-market surveillance), with what reviewers look for.Read the guide
- How to Build an MDR Technical FileA practical sequence for building an MDR technical file: intended purpose, classification, GSPR, risk, verification, clinical evaluation, labelling, PMS and final review.Read the guide
GSPR
Annex I requirements and how to evidence them.
Clinical evaluation
CEP, literature, equivalence and the CER.
PMS / PMCF
Post-market surveillance, PMCF, PSUR and vigilance.
ISO 13485
Quality management systems for medical devices.
CAPA
Corrective and preventive action that actually closes problems.
Audit
Gap analysis and preparation for notified body audits.
- MDR Gap Analysis GuideHow to run an MDR gap analysis on a technical file and QMS: scope, inputs, a structured review by Annex, prioritisation of findings and turning gaps into a plan.Read the guide
- MDR Audit Preparation ChecklistA practical checklist for notified body QMS audits and technical documentation reviews under the EU MDR, including unannounced audits, records to have ready and how to rehearse.Read the guide
AI & Regulatory
Using AI in regulatory work with proper controls.
Choosing software
Neutral criteria for evaluating MDR software.
- MDR Technical Documentation Software ComparisonA neutral framework for comparing MDR technical documentation software: criteria, questions to ask vendors, a scoring template and what MDRpilot does and does not offer.Read the guide
- MDR Software for Small and Medium-Sized Medical Device ManufacturersWhat SMEs need from MDR software: small teams covering many roles, PRRC at disposal, limited budgets, consultant collaboration and a fast path from legacy files to MDR.Read the guide
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