How to Prepare Technical Documentation for BSI Submission
Submitting to the British Standards Institution (BSI) requires thorough preparation. This guide walks you through the essential steps.
Understanding BSI Requirements
BSI, as a notified body, reviews your technical documentation to ensure MDR compliance before granting CE marking.
Document Structure
Your submission should include:
- Device Description and Specifications
- Risk Management File
- Clinical Evaluation Report
- Design and Manufacturing Information
- Labeling and Instructions for Use
- Performance Evaluation
Software-Specific Requirements
For software as a medical device (SaMD):
- Software Development Plan per IEC 62304
- Software Architecture Documentation
- Software Verification and Validation
- Cybersecurity Risk Assessment
Submission Timeline
- Initial submission review: 2-4 weeks
- Technical review: 4-12 weeks
- Response to queries: Varies
- Certification decision: 1-2 weeks after final review
Ready to streamline your BSI submission? Captain Compliant helps organize and validate your technical documentation.