Technical documentation
Build a technical file that makes the evidence work together
For medical software, AI-enabled technologies and software-driven devices, technical documentation must connect the product definition, lifecycle records, risk management, clinical evidence, verification and post-market activities. MDRC develops and reviews that complete evidence system.
Why it matters
A technical file is more than a collection of documents
Notified Bodies and regulators assess whether the complete body of evidence supports the same device, intended purpose, claims and risk profile. Gaps usually appear at the interfaces between documents rather than inside one report.
One product story
The description, intended purpose, classification, claims, labelling and clinical strategy describe one consistent device.
Traceable evidence
Requirements and risk controls connect to implementation, verification, validation and benefit-risk conclusions.
Lifecycle control
Changes, complaints, clinical information and post-market trends keep the documentation current after market entry.
Connected documentation
The file brings the regulatory evidence into one architecture
The exact content depends on the device, applicable legislation and target market. For software and AI products, the architecture must also make the development lifecycle, cybersecurity, usability and algorithm-related evidence visible and traceable.
MDRC defines the structure early, identifies the evidence still required and keeps each workstream aligned as the product and submission develop.
How we help
From first structure to submission and maintenance
We can prepare a complete technical file, develop selected documentation, review an existing submission or coordinate the work of your internal and external specialists.
Plan the architecture
We define the applicable structure, deliverables, responsibilities, evidence dependencies and realistic submission pathway.
Develop the documentation
We prepare and coordinate the core regulatory, risk, clinical, software, labelling and post-market documents.
Review and reconcile
We identify gaps, conflicting claims, broken traceability and unsupported conclusions across the complete file.
Support assessment
We prepare the submission, coordinate responses to questions and update the documentation through certification and beyond.
Practical resources
Explore the required structure
Use our detailed checklists to review the main technical-documentation elements under the applicable EU framework.
Work with MDRC
Create a technical file built for assessment and lifecycle use
Tell us about your device, target markets, development stage and existing evidence. We will define the documentation scope, priorities and a practical route to a coherent submission.
Talk to MDRC
