Strategic Planning for Regulatory Roadmap
Implementing new regulations in the dynamic field of in vitro diagnostic (IVD) devices presents unique challenges. DeSia's expert team excels in formulating strategic plans to effectively navigate these challenges. We start by identifying the optimal commencement point, understanding potential obstacles, and devising solutions to meet and exceed the high standards expected by auditors and/or reviewers.
Expertise in IVD Device Performance
Our team's deep understanding of how IVD devices function, how their performance is measured, and the necessary regulatory requirements sets the foundation for our performance evaluation services. We approach each project with a goal-oriented mindset, considering factors like risk assessment, market share, and your specific objectives to ensure that your device aligns with evolving regulations and standards.
Ongoing Process for Demonstrating Compliance
Performance evaluation is not a one-time task but an ongoing process crucial to demonstrating the scientific validity, analytical performance, and clinical effectiveness of your IVD device. A key element of this process is presenting sufficient clinical evidence, extending to areas such as risk analysis, post-market surveillance (PMS), and post-market performance follow-up (PMPF).
At DeSia, we position you at the forefront of IVDR certification, balancing the benefit/risk ratio, leveraging existing clinical performance data, and addressing your clinical needs to support comprehensive compliance.
Comprehensive Performance Evaluation Report (PER) Services
At DeSia, we offer specialized services to prepare the Performance Evaluation Report (PER) for your IVD device. Our process includes:
- Safety and Performance Assessment: We evaluate essential safety and performance criteria, backed by clinical data.
- Benchmarking Through Comparative Analysis: We identify and compare your device against similar products to set performance standards.
- Targeted Literature Review: Our team sifts through clinical studies and articles relevant to your device, ensuring a comprehensive understanding.
- Detailed Report Development: We create in-depth evaluation reports by analyzing pertinent written materials.
- Risk Management Integration: These reports are seamlessly integrated into risk management procedures and product instructions.
- Collaborative Report Finalization: We work closely with you to refine the report, incorporating your input and making adjustments as needed.
Engage with DeSia for PER Services
For expert assistance in developing a Performance Evaluation Plan/Report, contact DeSia. Partner with us to achieve and surpass regulatory compliance and market preparedness for your IVD device.
