CE marking for medical devices (MDR & IVDR)

Do you develop software for the healthcare sector and need to market it in Europe? CE marking is mandatory for both medical device software (MDR) and in vitro diagnostic software (IVDR). We help you certify your software in accordance with European regulations, with a technical, agile approach tailored to the digital environment.

We combine technological expertise in medical device software with our specialization in European regulations. Drawing on our experience as Verifiers and Validators, we advise our clients from the design phase onwards on best practices in accordance with the applicable regulations. We help you avoid unnecessary paperwork, interpret the regulations clearly, and apply them to your actual product.

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Initial Assessment CE Marking

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Preparation of technical documentation

We help you prepare the technical documentation required to obtain CE marking

Software Verification and Technical Validation

We help you verify and validate your medical device.

Performance Evaluation (IVDR)

It is an essential pillar of the IVDR (EU 2017/746). Its purpose is to demonstrate that your in vitro diagnostic device:

1. Fulfills its intended purpose.

2. Maintains the required levels of safety and performance.

3. Is supported by robust evidence throughout its entire life cycle.

Clinical evaluation (MDR)

Having solid safety and performance data is essential. We design your Clinical Evaluation Plan and prepare the Clinical Evaluation Report in accordance with MEDDEV 2.7.1 Rev. 4 and current MDCG guidelines, in order to:

Demonstrate the safety and performance of your product based on clinical evidence.
Systematically analyze the benefit-risk balance based on clinical evidence.
Support regulatory compliance with rigorous clinical evidence that backs up your technical documentation.

Usability Studies (IEC 62366-1)

We provide training on how to comply with these regulatory requirements. We help prepare all the associated documentation.

Post-marketing surveillance and monitoring

Post-market surveillance is a continuous process of collecting, analyzing, and interpreting real-world data on the use of your product to ensure that it remains safe and effective throughout its life cycle. Thanks to this feedback cycle, we can:

Detect any unexpected safety or performance signals early on.
Implement corrective and preventive actions to improve the product.
Maintain compliance with current regulations and the requirements of the Notified Body.

This proactive approach helps you anticipate risks, protect users, and strengthen confidence in your product.