Software complexity is changing the cybersecurity equation
Medical devices are becoming increasingly software-defined, bringing new levels of complexity and cybersecurity risk. As products become more connected and software-dependent, cybersecurity is no longer just an IT concern. It is directly tied to product quality, business risk, and most importantly patient safety.
Regulatory scrutiny is also increasing, placing greater emphasis on cybersecurity across both new and already-deployed products. For organizations managing large portfolios of devices in the field, responding quickly to vulnerabilities can be a significant challenge.
To keep pace, organizations must treat cybersecurity as an ongoing lifecycle responsibility rather than a point-in-time activity.
When cybersecurity data is disconnected, risk increases
Cybersecurity depends on information spread across engineering, quality, regulatory, and security teams. When that information is disconnected, risk increases and response becomes more difficult.
As cybersecurity expectations continue to expand across global regulations and standards, organizations need a more coordinated approach to manage risk and maintain compliance.
Cybersecurity requires a connected lifecycle
Cybersecurity is most effective when it is managed as part of the product lifecycle itself. Bringing together requirements, risks, testing, software composition, releases, post-market surveillance, and vulnerabilities creates a foundation for traceable execution, helping teams maintain visibility, accountability, and control as products evolve.
A connected lifecycle creates a shared system of record across engineering, quality, regulatory, post-market surveillance, and security teams. Rather than reconstructing evidence after the fact, organizations can embed cybersecurity into everyday product development and post-market activities while maintaining continuous readiness for evolving security and compliance requirements.
ALM is the backbone of lifecycle cybersecurity
Application Lifecycle Management (ALM) provides the foundation for executing cybersecurity across the product lifecycle. By connecting requirements, risks, verification, software composition, releases, and vulnerabilities, organizations can establish a shared system of record for cybersecurity execution and complete traceability.
This connected foundation enables teams to manage change safely, maintain governance across products and variants, and support structured medical software development processes. Predefined frameworks can help organizations get started faster while supporting compliance and quality objectives
Upcoming MedTech events
Extending cybersecurity execution into product context
A connected cybersecurity lifecycle starts with ALM, but effective cybersecurity also requires visibility into the products, configurations, and releases affected by risk. Connecting cybersecurity execution to the product record creates a cybersecurity digital thread that links engineering decisions to real-world product outcomes.
This broader context helps organizations understand exposure, coordinate remediation, and maintain continuity from development through deployment and ongoing product maintenance.
The ALM backbone
Connect requirements, risks, verification, software composition, releases, and vulnerabilities within a single lifecycle framework. Create the traceability needed to execute cybersecurity as an ongoing engineering discipline.
/en/products/codebeamerLink security requirements to product context
Connect cybersecurity requirements, risks, and vulnerabilities to product structures, configurations, and releases. Understand exactly where cybersecurity obligations intersect with the products you deliver.
/en/products/windchillAssess impact across products and variants
Understand which products, variants, components, and releases are affected when issues arise. Improve planning and decision-making by evaluating risk in the context of the entire product portfolio.
/en/products/pure-variantsConnect field events to engineering response
Gain end-to-end visibility into cybersecurity events across deployed products and engineering teams. Respond faster to emerging threats, reduce risk, and strengthen cybersecurity throughout the product lifecycle.
/en/products/ptc-orbitDrive closed-loop remediation
Move cybersecurity findings into governed engineering change processes. Ensure fixes are implemented consistently, validated appropriately, and tracked throughout the lifecycle.
/en/resources/application-lifecycle-management/product-brief/codebeamer-windchill-a-winning-combinationConnect security CAPA to design controls
Link cybersecurity-driven corrective actions directly to requirements, design controls, and validation. Strengthen root cause analysis and help prevent recurrence across future product iterations.
/en/technologies/plm/quality-managementMedTech cybersecurity advisors
PTC's MedTech experts help organizations navigate the intersection of cybersecurity, product development, quality, and regulatory compliance.
Rene Zoelfl
Senior Director & Global MedTech Advisor
Rene Zoelfl on LinkedInRene Zoelfl advises MedTech organizations on how to manage increasing product complexity, evolving regulatory requirements, and digital transformation initiatives across the product lifecycle. He works with medical device manufacturers worldwide to improve traceability, strengthen compliance readiness, and connect engineering, quality, and regulatory processes to support innovation while reducing risk. His expertise includes lifecycle management, software-driven product development, cybersecurity readiness, and digital thread strategies for regulated environments.
Greg Wilcox
Regional Vice President, North America MedTech Sales
Greg Wilcox on LinkedInGreg Wilcox works closely with MedTech manufacturers to address the operational and regulatory challenges created by increasingly connected and software-driven medical devices. He helps organizations align technology investments with strategic initiatives such as cybersecurity, product quality, compliance, and lifecycle management. Greg brings extensive experience helping MedTech leaders adopt modern approaches that improve visibility, accelerate decision-making, and support secure product development and post-market operations.
Ingo Ulmer
Senior Regional Director, Central Europe MedTech Sales
Ingo Ulmer on LinkedInIngo Ulmer works with leading MedTech organizations across Europe to address growing demands for product traceability, regulatory compliance, and cybersecurity execution. With extensive experience supporting manufacturers navigating complex regulatory environments, including evolving European cybersecurity requirements, he helps organizations establish connected lifecycle processes that enable secure-by-design development, effective risk management, and continuous compliance throughout the product lifecycle.