Technical Documentation and Dossier
Complete technical documentation support for global regulatory submissions, built with accuracy, compliance, and market readiness.
- Regulatory-Aligned
- Comprehensive Documentation
- Expert Review
- Global Submission Support
- Faster Time-to-Market
OVERVIEW
What Is Technical Documentation and Dossier?
A Technical File (also known as a Design Dossier) is a comprehensive document that demonstrates the safety, performance, and compliance of a medical device with applicable regulatory requirements.
We support end-to-end Technical Documentation and Dossier for Class I, II, and III devices as per global regulatory standards such as EU MDR, FDA, and other international requirements.
OUR SUPPORT INCLUDES
Our Support Includes
Design & Development Documentation
Support for design inputs, outputs, verification, and validation.
Risk Management Integration
Alignment with ISO 14971 and benefit-risk analysis.
Regulatory-Compliant Structure
As per EU MDR Annex II/III/XIV, FDA 510(k) or PMA requirements.
Clinical Evaluation & Post Marketing Surveillance
Integration of CEP, CER, and PMS data.
Documentation Templates
Use of industry best practices and templates.
Expert Review & QA
Internal review to ensure completeness and consistency.
OUR PROCESS
Our Process
01
Requirement Analysis
Understand product, classification, and target market requirements.
02
Plan & Structure
Define documentation plan as per applicable regulatory standards.
03
Develop & Compile
Prepare and organize technical file with supporting evidence and test reports.
04
Review & Finalize
Internal QA review and submission-ready file delivery.
Key Deliverables
- Complete Technical File / Design Dossier
- Device Description & Intended Use
- Design & Development Documentation
- Risk Management File (ISO 14971)
- Clinical Evaluation & Post Marketing Surveillance
- Verification & Validation Documentation
- Biocompatibility, Sterilization & Packaging Data
- Labeling and IFU Documentation
- Regulatory Submission-Ready File
APPLICABLE STANDARDS
Applicable Standards
EU MDR 2017/745
21 CFR 820 (QMSR – USA)
ISO 13485
ISO 14971
ISO 10993
ISO 11607 (Packaging)
Why Choose Medscape?
- Deep domain expertise in medical device regulations
- End-to-end documentation support
- Structured, audit-ready technical files
- Experience across Class I, II, and III devices
- Support for global market submissions
Need Support with Technical Documentation and Dossier?
Get expert guidance and end-to-end documentation support for your medical device.