Cybersecurity in medical devices is a required component of every regulatory submission. It is often far more expensive than it needs to be.
Cybersecurity in MedTech does not have to add dramatic schedule or financial burden when started early and integrated into the standard design and development process. Strategically embracing cybersecurity development in alignment with international standards assures compliance across jurisdictions.
If you are behind on cybersecurity, there are best practices that will speed your path to compliance. And if you have a legacy device in the field, learn how to bring that device into compliance with current regulation.
Grow your knowledge on how to comply with regulatory requirements and assure your device is safe from cyber attack.
Sign up hereKey Learning Objectives
- Understand how IEC 81001-5-1 can serve as a unifying framework for medical device cybersecurity across the Total Product Lifecycle and support global regulatory compliance.
- Learn how to integrate cybersecurity activities into existing QMS, risk management, and IEC 62304 development processes without creating unnecessary complexity or parallel workflows.
- Understand how security requirements, threat modeling, risk assessment, secure design, testing, traceability, labeling, and postmarket activities work together as a cohesive lifecycle process.
- Identify practical approaches for implementing IEC 81001-5-1 for new development and addressing cybersecurity gaps in legacy or transitional medical devices.
