Digital Testing for Medical Device
- Medical devices and healthcare systems represent a growing risk to hospitals and medical centers. The threat is not only to sensitive data, but to lives as well. Health care organizations typically have 300%-400% more medical equipment than other IT devices and as a result, securing and managing them can be overwhelming. Ensuring that these devices are secured and managed properly is critically important.Securing medical devices starts in the design phase and should be considered throughout the system development lifecycle. Ensuring proper controls are in place and vulnerabilities are identified should be central to a manufacturer’s SDLC methodology. As a result, cyber security has become a key factor in business competitiveness and differentiation.This conference will provide a wide and comprehensive overview of the most critical aspects and challenges in digital health application development and cyber security criteria to ensure medical devices meet the highest standards.
This conference offers a rewarding experience and is particularly relevant to those directly involved or supporting engineering activities, also those responsible for medical software development.
- 9.00 – 9.30: Registration
- 9.30 – 10.30: Challenges in digital health application development Moshe Klaiman (Medix)
- 10.30 – 11.00: Cybersecurity in Medical Devices – regulatory overview Orly Shenkar (Li-Med)
- 11.00 – 11.15: Coffee break and refreshments
- 11.15 – 12.45: Eurofins cyber security overview:
• Specific security services
• Device security overview (Medical, IoT, mobile, smart, etc.)
• Medical device security Marcel Mangel (Eurofins Cyber Security Services) - 11.00 – 11.15: Coffee break and refreshments
- 12.45 – 13.45: Lunch
- 13.45- 15.00: UL 2900 standard & Testing methodology Marcel Mangel (Eurofins Cyber Security Services)
- 15.00 – 15.15: Coffee break
- 15.15-16.30: Engaging the cyber security team & Logistics and service delivery Marcel Mangel (Eurofins Cyber Security Services)
- 16:30-17:30: One on one personal meeting
Marcel Mangel
Former Chief Technical Officer of TÜV SÜD Digital Service is now working as the managing director of Eurofins Cyber Security Germany. He has over a decade of experience in the world of
offensive as well as defensive cyber security and works part time as an assistant professor for IT security at the University of Applied Sciences in Rosenheim. Marcel also holds a masters degree
in computer science as well as several renowned IT security certifications.
Moshe Klaiman
Moshe is CEO of Medix which is a Medical Software powerhouse that has been specializing for the last 10 years in the development of the following services exclusively in the medical arena,
offering software turn-key and development services such as cloud, backend, web, mobile, application, healthcare interfaces (DICOM, HL7 and others) solutions, digital healthcare platform
solutions, and Software V&V (62304, FDA, CE). Moshe is an experienced manager in the medical field, leading business and engineering activities and an expert in medical software development
in the world of regulation (62304) and modern development methodologies (Agile, CI/CD and more).
Orly Shenkar
Orly’s is a QA/RA expert with a BSC & MSC in Biotechnology and more than 7 years of experience. Her professional path in the QA/RA world started in Direx and Biocontrol medical, where
she managed the QA engineering team. Orly has a strong professional background and solid managerial skills which allows her to manage regulatory projects and quality assurance for companies in the medical device field.