Technical File
Explore our services
- We specialize in the preparation and management of Technical Files – or Device History File (DHF) – ensuring that your technical documentation complies with EU MDR 2017/745.
- Our experts assist in writing and compiling key sections of the DHF.
- Our services are tailored to meet the specific requirements of your medical device to align with both MDR & IVDR guidelines.
We offer a comprehensive service to guide medical device manufacturers through the approval process, ensuring access to multiple markets.
We are also there when expansion to new markets becomes a strategic goal.
We support our clients with product registration ensuring your Medical Device is ready for market entry.
Once MDR certification is achieved, the work does not end.
We help clients maintain and evolve both their Quality Systems and Technical Files.
We are your End-to-End Partner in MDR.
Our high focus areas include:
Clinical Evaluation
Our medical writers have deep understanding across multiple clinical applications and device types and are experienced in supporting manufactures and clinical evaluators with authoring the MDR compliant clinical documentation.
Biological Evaluation
We provide comprehensive Biological Evaluation Plan (BEP) and Report (BER) and supporting documentation.
Our biological evaluations are guided by ISO 11193 and are tailored to each product specific materials.
Post-Market Surveillance (PMS)
The PMS requirements are particularly demanding under MDR, and a system for supplier qualification in life sciences is also important, as this area is under increased scrutiny.
We are of course supporting you in all key sections of the Technical File, including but not limited to:
- Risk Classification Determination
- Intended Purpose
- Design & Development Plan
- GSPRs (General Safety and Performance Requirements)
- Device Description & Specifications
- Product Requirements
- Verification Plan & Report
- Usability Engineering
- Risk Management File
- Clinical Evaluation Documents Package (CEP, CER, PMCF Plan and Report)
- PMS (Post-Market Surveillance)
- Biocompatibility
- EC Declaration of Conformity