Technical documentation support for medical devices and IVDs
Abingdon AI & MedTech
Technical file and design dossier
Technical documentation is the foundation of regulatory approval and ongoing compliance. Abingdon AI & MedTech supports diagnostics and medical device developers and manufacturers with the development, implementation, review and strengthening of technical files, design dossiers and supporting evidence. Our team of MedTech regulatory professionals helps ensure documentation aligns with FDA, EU/UK MDR and IVDR requirements, enabling efficient product approvals and market access.
What we deliver
Technical documentation services
Technical & Design File Review
Technical files often accumulate years of revisions, legacy documentation and changing regulatory requirements. Our review services help manufacturers understand what is missing, what is outdated and what may attract regulatory questions during assessment.
Clinical Evaluation Reports
Regulatory reviewers want to understand not only what evidence exists, but whether that evidence genuinely supports the claims being made. We develop and defend clinical evidence packages that stand up to scrutiny and support a clear benefit-risk argument, in partnership with our clients.
Biocompatibility & Biological Safety Evaluation
Biological safety and biocompatibility assessments play a key role in demonstrating the safety of medical devices and diagnostic products. Our experts help healthcare AI and MedTech firms navigate biological evaluation requirements by developing Biological Evaluation Reports (BERs), Biological Evaluation Plans (BEPs) and supporting ISO 10993 compliance activities. We work closely with client teams to identify and assess biological risks, gather the necessary evidence and ensure regulatory expectations are met as part of a robust technical documentation package.
Sterilisation & Bioburden
For medical devices requiring sterilisation, regulators expect the technical file to explain how sterility will be achieved and maintained throughout the stated product shelf life. The supporting documentation must also show that the chosen sterilisation process is appropriate for the device and remains under effective control.
Abingdon AI & MedTech works with developers and manufacturers to review sterilisation requirements and prepare the related evidence for inclusion in technical files or design dossiers. This may involve assessing existing documentation, identifying missing information, conducting supplier validation activities and closing gaps across all areas ahead of regulatory review. Our specialists can also help ensure that bioburden considerations are reflected appropriately within the wider product documentation.
At a glance
Key Technical Documentation Elements
Technical File / Design Dossier
Demonstrates regulatory compliance and product safety
Clinical Evaluation Report (CER)
Supports clinical evidence requirements
Biological Evaluation Report (BER)
Demonstrates biological safety
Risk Management Documentation
Identifies and controls product risks
Performance & Validation Data
Supports product claims and intended use
Our approach
Ready for the Next Stage of Your Product Journey?
Our team supports molecular diagnostics, immunoassays, lateral flow assays, point-of-care technologies and medical devices with practical regulatory, clinical and quality expertise. Whether developing a new technical file, remediating existing documentation or preparing for MDR and IVDR compliance, we provide hands-on support tailored to your products and target markets.
From the Knowledge Centre
AI & MedTech insights
Practical guidance from the specialists who deliver this work every day.
Frequently asked questions
Technical file and design dossier FAQs
A technical file is the collection of documentation used to demonstrate the safety, performance and regulatory compliance of a medical device. It typically includes design information, risk management documentation, performance data and evidence supporting regulatory approval.
Both documents support regulatory approval, but the structure and content requirements can differ depending on the product and regulatory pathway. Manufacturers often require a technical file or design dossier to demonstrate compliance with applicable FDA, MDR or IVDR requirements.
Documentation requirements may include technical files, risk management records, clinical or performance evaluation reports, biological safety assessments, validation data and supporting evidence aligned with MDR or IVDR requirements. The exact requirements depend on the product classification and intended use.
A Clinical Evaluation Report (CER) assesses the clinical evidence supporting the safety and performance of a medical device. CERs are commonly required as part of MDR technical documentation and regulatory submissions.
A Biological Evaluation Report (BER) assesses biological safety risks associated with a medical device and is often developed as part of an ISO 10993 biological evaluation strategy. BERs can form an important part of technical documentation submitted for regulatory review.
Yes. We support technical file reviews, design dossier reviews and technical documentation remediation projects for medical device, IVD and digital health manufacturers. These assessments help identify documentation gaps, strengthen submission readiness and support regulatory compliance.
Start the conversation
Talk to us about technical documentation support
Whether you need a technical file review, clinical evaluation support or biological safety assessment, Abingdon AI & MedTech can help. Our specialists work alongside your team to strengthen documentation, address compliance gaps and support successful regulatory submissions across the US, UK, EU and over 90 global regulatory territories.
- US, EU and UK market access
- ISO 13485, MDR, IVDR and FDA expertise
- Flexible support models