Technical Documentation Creation & Remediation
Technical documentation forms the evidentiary foundation of every conformity assessment under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). It substantiates that each device meets applicable General Safety and Performance Requirements (GSPRs) and maintains continuous conformity throughout its lifecycle. Despite its central importance, many manufacturers encounter significant difficulties in preparing or updating technical files to the standards expected by Notified Bodies. Inconsistent document structures, gaps in traceability, and misalignment between design, clinical, and risk management elements frequently lead to non-conformities and extended certification timelines.
Our Technical Documentation Creation and Remediation services provide a disciplined, end-to-end approach to building compliant, defensible, and logically structured technical files. We begin with a detailed assessment of existing documentation to determine its alignment with MDR/IVDR Annex II and III requirements and relevant MDCG guidance. Each document is reviewed for completeness, coherence, and consistency of evidence. Emphasis is placed on the interdependencies between the General Safety and Performance Requirements, design and risk management documentation, clinical evaluation, and post-market surveillance outputs.
Where gaps or inconsistencies are identified, we develop a targeted remediation plan that prioritises actions by regulatory significance. This includes re-establishing traceability matrices linking design inputs, verification and validation records, risk controls, and labelling content. We ensure that all claims made in clinical and marketing materials are substantiated by corresponding technical evidence, thereby reducing the likelihood of Notified Body observations.
For organisations developing new technical files, we provide structured authoring frameworks that ensure logical flow and standardisation across the document set. Templates and guidance are tailored to device class, technology type, and conformity assessment route. Our consultants support the creation of critical sections including device description, intended purpose, risk management summary, verification and validation data, clinical evaluation summary, and PMS/PMCF integration. Each file is formatted to facilitate Notified Body review, ensuring that the information hierarchy and cross-references align with reviewer expectations.
We also support the preparation of Design Dossiers or Technical Files for legacy devices transitioning to MDR or IVDR. These projects often involve consolidating historical data, updating risk analyses, and integrating new evidence to demonstrate compliance with the current regulatory framework. Our remediation methodologies are efficient and transparent, providing clients with clear documentation ownership and version control.
The benefits of a well-constructed technical file extend beyond regulatory approval. Comprehensive and coherent documentation enhances internal knowledge management, facilitates design transfer, and supports consistent post-market performance evaluation. It also enables more efficient change control and future product updates by establishing a clear baseline of device configuration and performance claims.
Our approach transforms technical documentation from a compliance obligation into a controlled, strategic asset that supports regulatory confidence and operational efficiency. We deliver documentation packages that withstand scrutiny, accelerate certification, and reinforce your organisation’s reputation for quality and reliability.
For further information on how our Technical Documentation Creation and Remediation services can enhance your conformity assessment readiness, please contact our regulatory documentation team.
