Medmarc

Event Details

Courtney Young to Speak at the Medical Device Cybersecurity Workshop

October 17, 2017 - October 18, 2017

Goodwin Law in Boston, MA

Cybersecurity for medical devices is mandatory.  FDA requires cybersecurity precautions both pre- and post-market and in remediation of legacy products.  Hospitals factor cybersecurity into purchasing decisions.  A lack of security may compromise your device’s performance and patient safety, and provide a point of entry to hospital HIT systems and other connected devices.

This two-day workshop provides thorough training in medical device cybersecurity risks, best practices for secure product design, validation and testing, postmarket surveillance, and procedures for incident response.  Small breakout sessions provide an opportunity for discussion of your company’s particular challenges and concerns.

You Will Learn:

  • Cybersecurity risks of medical devices and connected health systems
  • FDA and other government regulations and concerns
  • Cybesescurity standards
  • Hospital considerations and requirements
  • Products liability risks to manufacturers
  • Best practices for designing secure products
  • Coordinating cybersecurity and quality system procedures
  • Testing and monitoring product security
  • Remediation of legacy products

Speakers:

  • FBI Special Agent, Cybersecurity Division (a confirmed speaker, however, we are unable to name the person in an email)
  • Daniel Sutherland – Associate General Counsel, National Protection & Programs Directorate, US Dept. of Homeland Security
  • Suzanne Schwartz, MD - Associate Director, Science & Strategic Partnerships, CDRH, FDA
  • Laura Elan - Practice Leader, Digital health & Cybersecurity, Life & Health Sciences, UL
  • Stephanie Domas - Lead Security Engineer, Battelle DeviceSecure Services
  • Kevin Stoffell - Cyber Security Architect, Battelle
  • Rob Suárez – Director, Product Security, BD
  • Michelle Jump - Principal Regulatory Affairs Specialist, Stryker Corp
  • Michael McNeil - Global Product Security & Services Officer, Philips Healthcare
  • Stephanie Philbin - Counsel, Goodwin
  • Courtney S. Young - Senior Attorney, Risk Management, Medmarc Insurance Group

 Who Should Attend:

  • Product development
  • Software engineers
  • Regulatory
  • Quality
  • Compliance
  • Risk management
  • Senior management of smaller companies