Technical File & Risk management Services for MDR/IVDR Compliance
Ensure your medical devices and IVDs meet all regulatory requirements and maintain compliance throughout their entire lifecycle with Medivdpharma's (MIP) comprehensive technical documentation and post-market surveillance services. Our expert team guides you through the complexities of the EU MDR and IVDR, providing end-to-end support from initial submission to ongoing market vigilance.
Our Strategic Planning and Execution service offers a thorough approach to formulating and implementing business goals. We begin with an in-depth analysis of your business and market to identify opportunities and challenges. From there, we work with you to define clear, actionable objectives and develop a detailed.
Our Comprehensive Technical File Services
We develop complete, audit-ready technical documentation tailored to your device's risk class and type, ensuring full compliance with MDR or IVDR requirements.
- End-to-End Documentation Support: From simple compilation to authoring all key documents, we provide flexible support for a wide range of devices and device families.
- Critical Document Development: We specialize in drafting and refining the most challenging sections of your technical file, including:
- Clinical Evaluation Reports (CERs) / Performance Evaluation Reports (PERs)
- Risk Management File (Risk Management Plan & Report)
- Post-Market Surveillance (PMS) System
- Post-Market Clinical Follow-up (PMCF) / Post-Market Performance Follow-up (PMPF) Plans & Reports
- Technical File Review & Gap Analysis: For manufacturers with existing documentation, we conduct thorough reviews to verify MDR/IVDR compliance, identify gaps, and provide detailed guidance for remediation.
- Notified Body Strategy: We help you identify and prepare for engagement with the right Notified Body, ensuring a smooth submission process.
