Navigating the Regulatory Landscape with Precision
When introducing medical devices to the market, the burden of proof lies in demonstrating that your device meets performance standards while ensuring patient health and safety. DeSia's Clinical Evaluation process is a critical component in this journey, serving as a continuous assessment tool throughout your product's lifecycle, updated periodically to reflect current standards and findings.
Adherence to Regulatory Standards
The implementation of MDR 2017/745 since May 2020 has significantly broadened the scope for clinical data evaluation in medical devices. Complementing this, MDCG guidelines offers a comprehensive roadmap for both manufacturers and notified bodies, verifying alignment with the latest regulatory expectations.
Our Expert Approach in Clinical Evaluation Reports (CERs)
At DeSia, our team of experts diligently:
- Assesses General Safety and Performance Requirements: Identifying the necessary clinical data to support your device's compliance.
- Conducts Comparative Analysis: Finding and analyzing products similar or equivalent to yours to establish a baseline for safety and efficacy.
- Literature Review and Selection: Filtering clinical research and articles to find what is most applicable to your device.
- Creates Detailed Evaluation Reports: Analyzing written sources to develop comprehensive evaluation reports tailored to your device.
- Integrates Reports into Risk Management: Making certain that these reports are seamlessly incorporated into your device's risk analyses and usage instructions.
- Collaborates for Report Finalization: Presenting the final report to you for feedback and implementing any necessary changes.
- Facilitates Specialist Approval: Securing approval from a medical doctor specialized in your device's field, upon request.
- Supports in Report Presentation: Assisting your team in presenting the CER to your Notified Body or Competent Authority, if required.
Empowering Manufacturers for Market Approval
DeSia streamlines the process for market approval by carefully creating Clinical Evaluation documents, providing businesses with essential knowledge about their products' clinical uses, claims, and possible risks.
Get Expert Support for Your Clinical Evaluation Plan/Report
To enlist our support in preparing a clinical evaluation plan/report, please reach out to us.
