<h1>Ozlem Budakli</h1>

Ozlem Budakli

Ozlem Budakli joined Irdeto in 2022 as a quality manager for the Connected Health team. Her responsibilities include the implementation and maintenance of the quality management system, complying with ISO 13485, EU regulations and other regulatory bodies. She brings 10 years of experience in quality and regulatory business from the medical device manufacturers industry, and has also been a lead auditor in a notified body. Ozlem holds a Bachelor’s of Science in Biomedical Engineering, is a certified lead auditor and has a wealth of expertise in both risk and quality management.
The complexity of medical device cybersecurity requirements: How to cope 

The complexity of medical device cybersecurity requirements: How to cope 

by | Apr 25, 2023 |

Mitigating cybersecurity risks for medical devices is increasingly a core focus area for regulators, who are driving the establishment of a consistent cybersecurity framework to better facilitate coordination among all parties involved. This emphasizes the importance of Medical Device Manufacturers (MDMs) being aware of and familiar with the latest requirements. The intertwining of requirements, however, creates significant complexity in the medical device cybersecurity ecosystem. How can you cope with this?

Network Information Systems Security (NIS2) 101 

Network Information Systems Security (NIS2) 101 

by | Mar 29, 2023 |

A number of regulations have been put in place to help fortify medical devices and their manufacturing lines against potential attack patterns, including the revised Directive on the Security of Network and Information Systems (NIS2 Directive). The introduction of NIS2 will help form a better coordinated basis for cybersecurity action. Here’s what you need to know about it.

Coordinated Vulnerability Disclosure (CVD) 101 

Coordinated Vulnerability Disclosure (CVD) 101 

by | Dec 9, 2022 |

A Coordinated Vulnerability Disclosure (CVD) refers to a specific structured process where vulnerabilities are reported to organizations in a manner that allows for diagnosis and remediation before released to third parties or the public. CVD comprises of the coordination between the reporting entities and organizations with particular regard to the timing for both the remediation and publication of vulnerabilities. This blog post will explore the basics of CVD and what you need to be aware of.

Medical device cybersecurity: Conformity assessments 

Medical device cybersecurity: Conformity assessments 

by | Nov 17, 2022 |

The ongoing digitization in healthcare has brought not only new opportunities to improve patient care, but also challenges in cybersecurity. To address the issue and ensure the security of new medical devices, state-of-the-art regulatory frameworks are mandatory. Let’s discover some of the new industry developments, discuss the best practice documents and the implementation of the guidance.