Pre-Conference Workshop Day

Cybersecurity is emerging as an increasing issue for device manufacturers, from high profile attacks to mass
recalls. Most research to date has focused on the extent of the problem, and less on what actions medical device manufacturers can do to address the problem. This leaves many organisations with nowhere to focus their attention.

By considering full lifecycle approach, this can allow medical device manufacturers to consider the right control at the right time for managing cybersecurity risk. This session supports and builds upon new research on cybersecurity practices and focuses primarily on the solutions to the problem. Attend this workshop to share and learn about best practices for managing cybersecurity.

Session Objectives:
In this interactive session you will work within groups to discuss and identify key practices through the product lifecycle including:
- Device development activities, such as planning cybersecurity into device requirements.
- Device verification and validation activities, such as considering the value of independence
- Design transfer and manufacturing activities, such as configuration control.
- Post-market activities, such as updates, post-market surveillance and market withdrawal
- Compliance with current standards and regulations, such as the FDA guidance documents for cybersecurity

img

Hannah Murfet

Founder and Vice Chair, CQI Next Generation Network
The Chartered Quality Institute

11:30 AM - 1:30 PM Implementing Model-Based Designs in Medical Devices Workflow

2:30 PM - 4:30 PM Preparing for Your MDSAP Audit

Erich Zanner, Senior Quality Site Leader, GE Healthcare
Following on from our ‘teaser’ session in 2017, GE Healthcare will be back to give you all of the practical guidance and support you need to plan your MDSAP audit pathway.

With an annual audit that will get your device certified for five key medical device markets – and the incoming Canadian MDSAP audit requirement - the MDSAP program is the future of medical device auditing.
Speaking from personal experience of two MDSAP audits, GE Healthcare will help you become MDSAP audit ready.

- Understand the global reach and company impact of transferring to the MDSAP audit route
- Discover the finer details of the MDSAP from a QA expert, and figure out if it could help you save time and increase compliance
- Plan your MDSAP audit timeline – what do you need to be doing, and when?
- Develop an understanding of the numerous advantages and potential disadvantages of the program, to evaluate its value for your organisation
- Follow on from the 2016 Pilot program and look at the global role-out of the MDSAP audit – make sure your company is not left behind!

img

Erich Zanner

Senior Quality Site Leader
GE Healthcare