Regulatory Framework for Medical Devices

What can you expect from us?

We understand the challenges faced by SMEs in the medical device and in vitro diagnostic medical device industry when it comes to navigating the complex regulatory landscape. Thats why we offer comprehensive support in all steps of your regulatory pathways, ensuring that you can bring your innovative medical devices and in vitro medical devices to market with confidence.

How can we add value to your project?

Our regulatory services are fueled by our expertise in Cybersecurity, Artificial Intelligence, and Robotics, complemented by our highly skilled engineering team. We specialize in helping SMEs navigate the complex regulatory landscape and you can count us to add value to your products by:

• Implementation of the new European Regulation requirements (Regulation UE 2017/745 and Regulation UE 2017/746) for:
  • Implementation / update of the ISO 13485
  • Risk management and risk management gap analysis
  • Technical Documentation compilation
  • EUDAMED registration
  • UDI (Unique Device Identification) assignation
  • Process submission to a notified body
• Global Regulatory Requirements - CE Marking; USA FDA Market Access; UKCA Marking; ANVISA Registration
• Global Regulatory Strategy Advice
• Technical-regulatory support for electromedical device & medical software: gap analysis - design and development process, requirements and Cybersecurity
• Biological Evaluation Report, BER
• Clinical Evaluation and Clinical Evaluation Report, CER
• Person Responsible for Regulatory Compliance PRRC
• Post market surveillance system (including PMSRs and PSURs)

Check our previous experience:

Over the past two years, the MDRu has successfully supported more than 70 companies across the European Union, UK, and Brazil in obtaining the prestigious CE marking and FDA approval for over 150 medical devices and In Vitro Diagnostics Medical Devices. Additionally, we have provided regulatory training to over 300 individuals, thereby enhancing the internal knowledge base of these companies. We are dedicated to adding value to SMEs and supporting their success in the medical device regulatory.