COURSE - INSTANT STREAMING ACCESS
.addeventatc { background-color:#49b40c!important; color:#ffffff!important; font-size:13px!important; padding:6px 20px 6px 12px!important; /* extra right padding for icon */ border-radius:6px!important; display:inline-flex!important; align-items:center!important; gap:6px!important; /* spacing between text and icon */ position:relative!important; } /* Icon fix */ .addeventatc .addeventatc_icon { position:absolute!important; right:10px!important; /* push icon to right edge */ width:12px!important; height:12px!important; background:url(https://cdn.addevent.com/libs/imgs/icon-calendar-fff-t1.svg) no-repeat center center!important; background-size:14px!important; }
Share:

Cybersecurity Essentials for MedTech - Strategies to Fortify your Devices

This course strengthens the ability to identify medical device cybersecurity exposures, align security controls with FDA and ISO expectations, and improve lifecycle risk management decisions for connected healthcare technologies operating in regulated environments. This Course is designed for professionals responsible for regulated healthcare technologies, cybersecurity controls, compliance oversight, and device risk management.

REGISTER FOR THE COURSE

US $190 per learner

30-Days Unlimited Streaming Access

/* Hide default + / - icon */ .accordion-toggle-icon { opacity: 0; } /* Add circle instead */ .accordion-header::after { content: "○"; font-size: 18px; margin-left: auto; transition: 0.2s ease; } /* When open → filled circle */ .accordion-item.active .accordion-header::after { content: "●"; } /* Hide default + / - icon */ .accordion-toggle-icon { opacity: 0; } /* Add circle instead */ .accordion-header::after { content: "○"; font-size: 18px; margin-left: auto; transition: 0.2s ease; } /* When open → filled circle */ .accordion-item.active .accordion-header::after { content: "●"; } .accordion-header::after { content: "◯"; font-size: 18px; transition: transform 0.25s ease; } .accordion-item.active .accordion-header::after { transform: rotate(90deg); }

REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
/* Hide default + / - icon */ .accordion-toggle-icon { opacity: 0; } /* Add circle instead */ .accordion-header::after { content: "○"; font-size: 18px; margin-left: auto; transition: 0.2s ease; } /* When open → filled circle */ .accordion-item.active .accordion-header::after { content: "●"; } /* Hide default + / - icon */ .accordion-toggle-icon { opacity: 0; } /* Add circle instead */ .accordion-header::after { content: "○"; font-size: 18px; margin-left: auto; transition: 0.2s ease; } /* When open → filled circle */ .accordion-item.active .accordion-header::after { content: "●"; } .accordion-header::after { content: "◯"; font-size: 18px; transition: transform 0.25s ease; } .accordion-item.active .accordion-header::after { transform: rotate(90deg); }
  • Instructor : Charles Paul ‎ 
  • Study time : 60 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3761
  • Assessment & Certification Included
  • Ask the Expert

Watch the Course Now  

Watch the Course Now   

About the Course

Medical devices increasingly depend on interconnected software, wireless communication, and extended operational lifecycles, creating growing exposure to cybersecurity threats across healthcare environments. Weak security controls, outdated systems, and insufficient update practices can compromise patient safety, disrupt healthcare operations, and expose sensitive information. Regulatory agencies are placing greater emphasis on cybersecurity expectations for manufacturers and healthcare organizations, particularly where connected technologies influence clinical performance and data protection responsibilities.


This course examines the operational and regulatory realities surrounding cybersecurity in medical device technology, including embedded system vulnerabilities, healthcare network integration, and lifecycle security management. Particular attention is given to FDA, ISO, IEC, EU MDR, and NIST-related expectations affecting device manufacturers and healthcare providers. Real-world cybersecurity incidents and regulatory responses are used to illustrate practical risk management considerations, incident response planning, post-market responsibilities, and security measures that support ongoing device reliability and compliance readiness.

  • Strengthen Device Security and Lifecycle Risk Controls:

    Medical devices often remain in service for extended periods while relying on interconnected technologies and wireless communication. This course provides practical direction for identifying vulnerabilities, improving update and patch management practices, and developing lifecycle security controls that reduce operational exposure while supporting patient safety and device reliability expectations.

  • Improve Cybersecurity Compliance Readiness:

    Regulators increasingly expect manufacturers and healthcare organizations to demonstrate effective cybersecurity oversight throughout device development and post-market activities. This course clarifies FDA, ISO, IEC, EU MDR, and NIST-related expectations while helping professionals improve risk assessment processes, incident response planning, and documentation practices connected to cybersecurity management responsibilities.

Key Areas Covered

  • Growing cybersecurity risks affecting connected medical devices and healthcare infrastructure
  • Integration of medical devices within healthcare networks and operational technology environments
  • Embedded system vulnerabilities, wireless communication risks, and challenges created by outdated devices
  • FDA 21 CFR Part 11 & 820, ISO 13485, ISO/IEC 27001, EU MDR cybersecurity expectations, and NIST Cybersecurity Framework considerations
  • Risk assessment methods, incident response planning, and cybersecurity awareness practices for healthcare personnel
  • Device design considerations supporting security controls, deployment management, software updates, and end-of-life planning
  • Case studies involving cybersecurity incidents, regulatory responses, breach impacts, and mitigation activities
  • Emerging cybersecurity considerations connected to IoT, AI technologies, and future healthcare device environments

Who Must Attend

  • Quality Assurance Departments
  • Regulatory Affairs & R&D Teams
  • Software Development, Programming & Testing Teams
  • Manufacturing, Engineering & Operations
  • Production & Purchasing Departments
  • Medical Device Manufacturing Professionals

Quality training, expert insights, and answers that matter. Know your Expert

CHARLES PAUL

Charles Paul is an instructional designer and management consultant with more than 30 years of experience supporting regulated industries through training, quality systems implementation, and operational documentation development. His background includes work across pharmaceuticals, biotech, foods and beverage, cosmetics, and OTC consumer products industries. His experience designing GMP documentation systems and compliance-focused training programs supports the operational, quality, and regulatory considerations associated with medical device cybersecurity and connected healthcare technologies.

If you would like to request a Proforma invoice to sign up for this course. please click here

Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

Upcoming Courses

Your TalkFDA Webinar Experience

When you reserve your seat, everything is organized for you — from access to certification from one place.

1. Confirmation
You receive a confirmation email and your course appears instantly in your TalkFDA dashboard.

2. Your Course Hub
Your TalkFDA course page becomes your central hub where you can watch the course, access materials, and manage your learning.

3. Access course materials
The presentation handout and other materials can be downloaded inside the Course Player. You could use Discussion feature there to ask your questions.

4. Watch The Streaming and Complete your Course
The course playback will be available on the same course page. You could pause and continue or you can revisit important sections.
5. Earn Your Certificate
Complete the course and your certificate is unlocked automatically in your learning history.

The challenge with training is rarely signing up. It’s what happens afterward, when access, materials, & certification aren’t accessible from one place.
With TalkFDA Courses, Everything you need Live in One Place.
Simple. Organized. Professional.
Go ahead and Take the Course with confidence.

Our students love us ❤️

“Good balance. Not too basic, not too deep. Worked well for mixed team.”

Manager, Regulatory Affairs

“Presenter handled questions well. Didn’t avoid anything.”


Consultant, Compliance

“Session was easy to follow even for non-core team members. That helped.”

Officer, Production

People who took this Course, also viewed