Product Overview
MDD-MDR Transition Services
IZiel provides a “One-Stop Shop” to assist medical device manufacturers for MDD-MDR transition. IZiel ensures to focus on regulating medical devices throughout its lifecycle rather than focusing on any one stage, which is the need of MDR.
Our One Stop Solution Includes:
1. Gap Assessment
2. Technical File Preparation
3. QMS Documentation
4. Expert Review & Recommendations
5. European Authorized Representative (EC REP)
6. EUDAMED
7. Mock Audits & Trainings
8. PRRC Services
9. Clinical Evaluation Plan & Report
10. Software Validation
Our outcome based cost-effective model & comprehensive weekly reports have been our keen enablers of our success.
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