MDR Technical Documentation for Audit Readiness

Program Overview

This expert-led program equips medical device professionals with the knowledge and tools to create, maintain, and defend MDR-compliant technical documentation. Covering Annex II & III requirements, the integration of risk management (ISO 14971), clinical evaluation (CER), and post-market surveillance (PMS/PMCF) data, the course blends conceptual clarity with real-world case studies and interactive workshops. Participants will gain actionable strategies to structure robust technical files, close compliance gaps, and respond confidently to Notified Body audits, ensuring both regulatory success and smoother market access.

Features

Interpret and apply Annex II & III requirements for MDR technical documentation.
Build and maintain compliant technical files that integrate clinical, risk, and PMS data.
Identify and address common gaps highlighted in Notified Body audits.
Develop a corporate roadmap for documentation readiness and lifecycle compliance.

Target audiences

Regulatory Affairs Specialists & Managers
Quality Assurance & Compliance Professionals
R&D and Product Development Leaders
Technical Documentation & Project Managers

Curriculum

5 Sections
21 Lessons
1 Day

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Instructor

Huksa

Deep-domain, High Precision L&D - delivered directly by Renowned Industry Practitioners

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8 Students

267 Courses

Offered by Huksa, this L&D program is led by elite industry veterans—CXOs and Functional Heads with 25+ years of deep-domain expertise. You have the flexibility to customize the curriculum, select your preferred expert, and align the program to your organization’s specific objectives. Connect with the Huksa team to explore our array of top-tier trainers available for this course!

₹100,000

Duration 1 day
Lessons 21
Maximum Cohort Size 30
Language English
Skill level Mid-Senior Professionals
Certificate yes

1 Day, 8 Hours/day

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