Clinical Evaluation

Clinical Evaluation Service for Medical Devices under MDR 2017/745

We provide comprehensive clinical evaluation services for medical devices, ensuring compliance with the Medical Device Regulation (MDR) 2017/745 in Europe.

Key Features

  • Detailed Analysis: Our experts meticulously analyze clinical data, ensuring all necessary information is gathered for thorough evaluations.
  • Regulatory Compliance: We ensure your medical device meets all regulatory requirements under MDR 2017/745, facilitating smooth market entry.
  • Comprehensive Reports: We provide detailed and well-structured clinical evaluation reports, supporting your device’s safety and performance claims.
  • Continuous Support: We offer ongoing support throughout the evaluation process, helping you address any regulatory queries promptly.
  • Risk Management: Our evaluations include detailed risk assessment, identifying potential issues and ensuring proactive risk management.

Summary of Safety and Clinical Performance (SSCP)

We assist in drafting the Summary of Safety and Clinical Performance (SSCP), mandatory for implantable and class III devices. This document undergoes validation by a Notified Body and is publicly available via Eudamed, providing crucial information for healthcare professionals and patients

Additional Support

  • Clinical Evaluation Plan: We draft a comprehensive clinical evaluation plan tailored to your device.
  • Post-Market Clinical Follow-Up (PMCF): We assist in creating and executing PMCF plans, ensuring continuous monitoring of your device’s performance.

With our service, you can confidently navigate the complex regulatory landscape, ensuring your medical device meets the highest standards of safety and efficacy.

Why do you need this service?

Clinical evaluation is a key requirement under the European Medical Device Regulation (MDR). Failure to conduct a thorough clinical evaluation could lead to non-compliance, resulting in penalties or withdrawal of the product from the market.

Through clinical evaluation, manufacturers can assess the safety and performance of their medical device. It’s crucial to ensure that the device performs as intended without causing any adverse effects, ensuring patient safety.

Clinical evaluation is the heart of a medical device. But it is often the most complex and resource intensive part. We find the most effective way and focus on what matters.

Looking for Clinical Evaluation assistance?

Our comprehensive Clinical Evaluation service, in line with global regulation.

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