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Clinical

Clinical Evaluation of Medical Devices ›

Clinical evaluation is a key process in the medical device lifecycle. It begins at the very start of device development and continues throughout its entire lifetime. The aim is to ensure and demonstrate that the medical device is safe and performs as the manufacturer claims.

Literature search for medical devices ›

Conducting a thorough literature search for the clinical evaluation of medical devices is a crucial step in ensuring their safety, performance, and clinical benefits. This process is essential to make sure that all relevant data is considered, and that the clinical evaluation is robust and reliable.

Post-market Clinical Follow-Up ›

Post-Market Clinical Follow-Up (PMCF) is a crucial component of the post-market surveillance (PMS) activities required under the Medical Device Regulation (EU) 2017/745 (MDR).

Medical Device Clinical Investigations under ISO 14155 ›

Clinical investigations are crucial for ensuring the safety and efficacy of medical devices. Regulatory compliance, particularly with ISO 14155, plays a central role in this process.

Clinical Support for Your Medical Device

Medical devices play a crucial role in delivering healthcare services. Given their significant contribution to patients’ health, these devices must be safe and effective. This necessity has led to various regulations and standards that establish the framework for safety and performance requirements, particularly from a clinical perspective. Navigating these requirements can be challenging and demands specialized knowledge and experience.

What can we do for you?

Our medical device team has extensive experience and expertise to support you with:

  • Clinical evaluation
  • Clinical investigation (regulatory) compliance (ISO 14155 support)
  • Literature searches for medical devices
  • Post-Market Clinical Follow-Up
Konstantin Simočenko
Senior RA Manager
Konstantin Simočenko

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Learn how we can support you in meeting your business goals

  • Our lean and powerful team with degrees in pharmacy, chemistry, biology, or related studies strive to be of added value to you. Our short reporting lines enable the most efficient road to your success.
  • Having one point of contact from our experts backed by the team’s collective knowledge and resources we give reliable advice and execute projects seamlessly.
  • At Starodub, consistency and assurance of quality are vital. A quality management system has been implemented and we adhere to GxP and ISO 9001/13485.
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Industriestraat 14
5391 BR Nuland
The Netherlands
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Starodub – a team of experts in regulatory affairs

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Konstantin Simočenko
Senior RA Manager
Konstantin Simočenko

Let's Connect

Talk to an expert