STARTING WITH THE END IN MIND

MEDICAL
DEVICES

We help to navigate the scientific and regulatory requirements and provide high-level RA services for your products' clinical development from design, certification and post-approval requirements.

As clinical experts, we provide focus,  setting realistic milestones, identify risks, and align your goals with the requirements of Authorities.

MDR & IVDR Preparation

Notified body interactions

The MDR comes into effect in May 2020 and to ensure continuous compliance of your medical device products to the new legislation we have a comprehensive transition plan. 

Study Design & Medical Device Trials

From early pilot studies to post-market monitoring, we have all the necessary means to provide you with the clinical evidence you need.

Whether it is dealing with transitioning to another Notified Body or exploring your options in establishing a new relationship. We can assist you based on years of interacting with many of them.

Risk management plan

Since the revised ISO 13485:2016 standard, there has been an increased emphasis on risk management. We go beyond compliance and aim to improve the allocation of an organization’s resources.

Quality Management System

Determining the status of your QMS and related processes to ensure that manufacturing, development, and related control facilities meet the applicable standards.

Technical file & CE Certification

We can organise the complete preparation, review, and submission of your Technical File to manage your CE certification.

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Strada Cozia 10, Timișoara 300425, Romania

Contact

       info@operacro.com

       +40.256.200.353