In this Medical device training will provide valuable assistance to regulated companies on how to drive regulatory compliance for IT based medical devices.
Hospitals have increasing concerns that medical IT systems will endanger patient safety if security updates like MS security patches are not applied. There is backlash from hospitals against medical device vendors that prevent these updates from occurring or cause unnecessary delays. The FDA is encouraging complaints to be reported against the manufacturer in incidents that may lead to death or serious injury where a device becomes unstable do to lack of security or virus updates. Many vendors expect their Medical IT devices to stay static and will not authorize patch updates. Security flaws can result in systems that do not function as intended and can represent a significant risk to patient safety. Keeping such a device static is contradictory to ensuring that such a device is safe and effective per its intended use.
Of course, hospital IT departments may address the risk of these un-patched systems by applying these patches without the vendor’s approval causing potentially new undocumented risks to the medical device. Manufacturers must take the lead and drive regulatory compliance for these IT based medical devices.
Hospitals have increasing concerns that medical IT systems will endanger patient safety if security updates like MS security patches are not applied. There is backlash from hospitals against medical device vendors that prevent these updates from occurring or cause unnecessary delays. The FDA is encouraging complaints to be reported against the manufacturer in incidents that may lead to death or serious injury where a device becomes unstable do to lack of security or virus updates. Many vendors expect their Medical IT devices to stay static and will not authorize patch updates. Security flaws can result in systems that do not function as intended and can represent a significant risk to patient safety. Keeping such a device static is contradictory to ensuring that such a device is safe and effective per its intended use.
Of course, hospital IT departments may address the risk of these un-patched systems by applying these patches without the vendor’s approval causing potentially new undocumented risks to the medical device. Manufacturers must take the lead and drive regulatory compliance for these IT based medical devices.
Areas Covered in the seminar:
- Presenting current regulatory and industry viewpoints on this critical issue
- Showcasing how taking the lead benefits the vendors in setting the standard and ensuring high product quality in this very competitive industry
- Expounding on the weaknesses in vendors approaches to security and patch update validation and offering strategies that are adaptable and efficient to meet customer and regulatory requirements
Who Will Benefit:
This Webinar will provide valuable assistance to regulated companies on how to drive regulatory compliance for IT based medical devices. The employees who will benefit include:- Regulatory & Compliance Management
- Quality Systems Management
- Hospital IT Management & Staff
- Software/IT System Validation Management & Staff
- Internal and External Auditors
Course Provider
Lori Kahler,
