With the implementation of 2017/745 MDR and 2017/746 IVDR, security requirements for medical devices capable of network connectivity have increased. New essential safety requirements have been established for electronic programmable systems and software-based medical devices. Manufacturers must design and produce their products in accordance with the latest technology, incorporating risk management principles, including information security, and establishing minimum requirements for Information Technology (IT) security measures to protect against unauthorized access. Cybersecurity must be integrated from the design phase and maintained throughout the entire lifecycle of the product.
We provide testing and evaluation services in compliance with the cybersecurity requirements of the Medical Device Regulation (MDR) (EU) 2017/745, In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746, and the U.S. Food and Drug Administration (FDA) for the Internet of Medical Things (IoMT) in collaboration with our strategic partner, ISTEC Cyber Security. Ensuring the security of medical devices is crucial for patient privacy and data integrity. Therefore, security solutions that align with MDR, IVDR, and FDA standards are developed to identify potential vulnerabilities in IoMT devices and offer manufacturers reliable and effective solutions.
In this process, which aims to comply not only with global regulations such as MDR and FDA but also with specific requirements like ETSI EN 303 645, we assess and report cybersecurity vulnerabilities in devices and provide manufacturers with improvement recommendations. Together with our strategic partner, ISTEC Cyber Security, we support manufacturers in creating a secure healthcare technology ecosystem.
IoT Test and Evaluation Services
Our cyber security testing services cover the following topics:
- Hardware Test
- Software Test
- Communication Test
- Wireless Communication
- Wi-Fi
- Bluetooth
- RF (Radio Frequency)
- Wired Communication
- GDPR Compliance Test
- ETSI EN303 645
- TR-TEST IoT Product Criteria
With these comprehensive services, we help medical device manufacturers develop safe products that meet market requirements.
