Medical device cybersecurity is coming under ever-increasing scrutiny.
Demand for demonstrable, well-integrated security is being driven not just by regulation, such as the FDA's Guidance for Premarket Submissions (due to be updated this year) and the EU MDR.
It's also being driven by purchasers of medical devices at healthcare delivery organizations (HDOs) - hospitals and in-home care providers - and, in a negative sense, by cyberattackers looking to exploit the medical sector's historically notoriously insecure devices and the systems to which they're connected.
In this webinar, industry expert & co-author of Medical Device Cybersecurity for Engineers and Manufacturers Christopher Gates will explain how participants can integrate security into existing medical device development processes, resulting in secure products and needed artifacts for regulatory submission and sales, with minimum burden on budgets and schedules.
You will learn what, when, and how to implement security activities into development so that your devices will protect your patients, your clients, and your business model.
Regulatory Affairs Professionals and Management
Greenlight Guru is the only quality management software platform designed specifically for medical device companies. The platform helps companies bring safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more. Greenlight Guru’s platform is used by thousands of users across the globe to push beyond baseline compliance and achieve True Quality for their medical devices. Visit our homepage to learn more.
Velentium is a professional engineering firm, specializing in the design and manufacturing of therapeutic and diagnostic active medical devices. Velentium utilizes a Secure Development Lifecycle. We believe the best way to ensure a secure system is to weave security throughout the entire development process (similar to risk management per ISO 14971 and harmonized with IEC 62304). We have experience working with all sizes of clients, ranging from startups seeking seed funding to established Fortune 500 companies. We exist to transform your IP into a safe and secure product that will change lives for a better world. Visit our website to learn more.