Regulatory Affairs & Technical Documentation That Secures Global Approval
Navigate complex regulatory pathways with confidence. Our team of former Notified Body experts, regulatory specialists, and medical writers deliver compliant technical documentation and strategic regulatory guidance for IVDR, MDR, FDA, UKCA, and global markets.
Regulatory Excellence for IVDs & Medical Devices
At MDx CRO, we transform regulatory challenges into competitive advantages. Whether you’re navigating IVDR transition, preparing MDR technical documentation, or planning a global regulatory strategy, our team provides expert guidance and hands-on support across the entire product lifecycle.
Our regulatory affairs and technical documentation services span all device classes and risk categories-from Class I medical devices to Class D IVDs-ensuring your submission packages are scientifically sound, technically precise, and fully aligned with regulatory requirements.
Led by former Notified Body and regulatory authority reviewers, we deliver the expertise you need to achieve compliant, efficient, and successful outcomes for your medical technology.
Comprehensive Regulatory & Technical Documentation Services
Regulatory Strategy & Intelligence
Global Regulatory Pathway Determination
Regulatory Intelligence
Pre-Submission & Scientific Advice
Technical Documentation Development
Technical File & Design Dossier Creation
GSPR Documentation
Risk Management
Performance Evaluation & Clinical Evidence
Performance Evaluation Plans & Reports
Clinical Evaluation
Post-Market Surveillance Planning
Regulatory Submissions & Authority Communications
Notified Body Submissions
Competent Authority & Regulatory Body Interactions
FDA, UKCA & Global Submissions
Legal Representative Services & Regulatory Operations
European Authorized Representatives
EUDAMED Registration & UDI
Document Control & QMS Integration
Our Differentiated Expertise
| Capability |
|---|
| Former Notified Body Experts |
| Mock NB Reviews |
| IVDR/MDR Focus |
| Combined RA & Clinical |
| Device-Specific Templates |
| Therapeutic Area Knowledge |
| GSPR/Standards Expertise |
| Global Strategy Integration |
| MDx CRO | Typical CROs |
|---|---|
 From top EU NBs including BSI |  Limited or none |
| Actual former NB reviewers | Often by consultants with no NB experience |
| Specialists in current regulations | Often transitioning from older directives |
| Integrated services |  Usually separated departments |
| Customized for your technology | Generic templates |
| Deep clinical understanding | Generalized approach |
| Standards specialists on staff | Basic knowledge only |
| EU, UK, US & global | Region-specific expertise |
Former BSI, TÜV SÜD reviewers on staff
Multiple first-of-kind device approvals under IVDR/MDR
Annex II/III Technical Documentation authored and remediated across all risk classes
A global IVD manufacturer needed to transition 15 assays from IVDD to IVDR within 12 months, with significant gaps in technical documentation and clinical evidence.
MDx implemented our structured Technical Documentation Remediation Process, with specialized teams for performance evaluation, risk management, and labeling compliance.
All 15 assays successfully certified under IVDR with a single round of Notified Body review, completed 2 months ahead of deadline.
A novel combination product with both medical device and IVD components required a clear regulatory pathway under both MDR and IVDR.
MDx conducted a comprehensive classification assessment, consulted with authorities, and developed an integrated regulatory strategy leveraging both frameworks.
Client secured clarification on primary regulation, optimized testing requirements, and reduced time-to-market by 6 months.
Our Technical Documentation Process
- Comprehensive review of existing documentation
- Gap analysis against target regulations
- Regulatory strategy development
- Prioritized action plan development
- Resource allocation and timelines
- Template creation and content planning
- Technical writing by domain experts
- Evidence compilation and analysis
- Cross-referencing and consistency checks
- Multi-stage quality control process
- Mock Notified Body review
- Compliance verification
- Submission package preparation
- Notified Body communication management
- Deficiency response coordination
Frequently Asked Questions
Ask us a Question- How long does it typically take to remediate technical documentation for MDR/IVDR compliance?
Timelines vary based on device class and documentation maturity but typically range from 3-8 months for complete technical documentation remediation. Our assessment phase provides a precise timeline for your specific product.
- Can MDx support both IVD and medical device technical documentation in the same project?
Yes. We have specialized teams for both IVDs and medical devices, with experts in specific technology areas like software, combination products, and companion diagnostics. For products with both components, we provide integrated support with teams working in parallel.
- What advantages do former Notified Body reviewers bring to technical documentation development?
Our former NB experts understand exactly how submissions are reviewed, common deficiencies, and what constitutes acceptable evidence. This insider knowledge ensures documentation is structured optimally, addressing potential concerns before they become findings.
- How do you stay current with evolving regulatory requirements?
Our Regulatory Intelligence team continually monitors updates from authorities (EMA, FDA, MHRA), notified bodies, and industry groups. We maintain relationships with regulatory bodies, participate in industry working groups, and immediately incorporate new guidance into our processes.
- Can you support global submissions beyond EU and US markets?
Yes. We support submissions in major and emerging markets worldwide, including UK, Canada, Australia, Japan, Brazil, and China. Our global regulatory strategy ensures efficient leveraging of core documentation for multiple markets.
- What is your approach to GSPR compliance documentation?
We follow a systematic approach to GSPR compliance, mapping applicable requirements, identifying relevant standards, assessing compliance with each requirement, and documenting evidence. Our approach ensures complete traceability between requirements, standards, and verification evidence.
Expert Technical Documentation for Your Regulatory Success
Whether you’re facing IVDR/MDR transition, preparing for Notified Body submission, or developing a global regulatory strategy, MDx delivers the expertise and execution you need to navigate requirements confidently and efficiently.
From Concept to Compliance. We Deliver.
