Cybersecurity as a Design Input - Reminder

Cybersecurity risk presents a distinctive challenge to manufacturers and hospitals alike. Threats and vulnerabilities cannot be eliminated. The health care environment is complex, making cybersecurity risk reduction especially challenging.

All legally marketed medical devices distributed worldwide have benefits and risks. Regulatory agencies clear, authorize, or approve devices to be marketed in their respective geographies when there is assurance that the devices are safe and effective for their intended use with reasonably reduced risk. Manufacturers are responsible for identifying and mitigating these risks.

Mitigating cybersecurity risk starts as the device is being designed, so integrating cybersecurity risk mitigation in the Design Control process is the best way to begin! Key focus areas will include:

1. Designing secure software

o Integrate cybersecurity measures throughout the product development lifecycle.

o Align with your company’s Quality Management System (QMS) to ensure consistent application of cybersecurity practices.

2. Assessing security risk management requirements

o Identify and utilize available resources to translate security requirements into practical applications.

o Develop a comprehensive approach to managing security risks associated with medical devices.

3. Regulatory Submission Integration

o Embed cybersecurity risk considerations into your regulatory submission processes for 510(k), de novo, or PMA pathways.

This discussion aims to equip compliance practitioners with actionable insights and processes for navigating cybersecurity requirements effectively, paving the way for successful device market entry.

Registration: Go to: https://mp.gg/g3hrqbarnh

Or scan the QR code here:

Program discounted rate:

· Registration Fee - $99, including dinner. Registration ends on November 13. A Waitlist is available after that date.

Location:

MedAcuity

210 Littleton Road

Westford, MA 01886

Program Time/Date:

November 20, 2024, 4:00 PM- 8:00 PM

Speakers include:

Scott Blood, Vice President of Quality and Regulatory Affairs, T2 Biosystems Inc.

Scott brings over 30 years of medical device experience and has held leadership positions at past companies such as Solace Therapeutics, NinePoint Medical, Candela Corporation, InfraReDx, Fossa Medical and PercuSurge. He is the Past Chair of both ASQ Medical Device Division and the New England Discussion Group, a former member of the Board of Directors of the Massachusetts Medical Device Industry Council (MassMEDIC), a member of the Regulatory Affairs Professionals Society (RAPS), and a frequent lecturer on quality, clinical and regulatory topics relevant to the medical device industry. Scott holds a BS degree from Wentworth Institute of Technology, as well as CQE and CQA certification through ASQ and RAC-Devices through RAPS.

Normand Martel, Senior Solutions Architect – MedAcuity

Norm is an experienced hands-on solution architect with an extensive background in hardware and software specializing in systems engineering, safety critical embedded systems, signal processing, wireless, and cybersecurity across the full product life cycle.

Event Refund Policy:

We unfortunately cannot offer refunds for cancellations made within 1 week of this event. Refunds requested prior to one week will be honored, however, the sign-on fees from Member Planet will be charged. Substitute or replacement people are always permitted. Please contact the program chairs listed if a change is to be made to ensure we have the most up-to-date information on the event’s attendee.

Please send all questions to the Co-Chairs about this event: Scott Blood (scottqara@gmail.com) or Jennifer Almy (qualityjen@gmail.com)