Medical Device Technical Documentation Review & Support for Medical Devices
We support the creation, review, and maintenance of medical device technical documentation in line with applicable regulatory requirements. Our focus is on clear structure, traceability, and documentation that supports both regulatory submissions and ongoing compliance.
Medical Device Technical Documentation Services for EU MDR and FDA Compliance
Audit-ready Medical Device Technical Documentation that supports global approvals
We provide a comprehensive technical documentation review service to ensure your files are clear, logically structured, and fully compliant with EU MDR and FDA requirements. By focusing on precision rather than unnecessary complexity, we ensure your technical file accurately reflects your product’s design and clinical performance.
Our streamlined approach to technical documentation review is designed to minimize follow-up questions from Notified Bodies and national authorities. Consequently, we help you avoid costly delays and maintain a predictable timeline for market access and CE marking.
FDA Submission Kickstart
This service gives you an early, structured view of what an FDA submission will require for your specific device. We help determine the FDA regulatory classification and the activities that follow from it, then walk you through the FDA submission package, explaining the purpose of each section and what documentation is typically expected. We also support the pre-submission process, helping you reduce uncertainty and move forward with a clear and confident regulatory strategy.
EU MDR Kickstart
This service provides an overview of the EU MDR framework and explains how regulatory requirements translate into concrete documentation, testing, and processes. We outline the structure of the Technical Documentation and describe the role of key elements such as the GSPR checklist, risk management file, clinical evaluation, PMS/PMCF, and labeling.
Technical Documentation and Review Service
We help document and review selected parts of your existing Technical Documentation against EU MDR or FDA expectations, focusing on structure, completeness, and traceability. The service highlights areas that require clarification, additional evidence, or alignment with quality system processes.
Verification & Validation Planning Support
We help define a V&V strategy that supports regulatory submissions. This includes identifying required evidence, aligning test plans with standards, and ensuring traceability to requirements and risks.
Regulatory Submission Support
We provide full support for medical device regulatory submissions, either for the U.S. market (FDA) or the European market (EU MDR). Our support covers the planning, preparation, coordination, and review of all required documentation, aligned with applicable regulatory frameworks and standards.
Ensure your medical device technical documentation is audit-ready
Our expert review service identifies gaps and ensures EU MDR/FDA compliance. Book a gap analysis.