This work instruction provides detailed instructions for a security incident response to a cybersecurity incident.
Security Incident Response Planning (WI-008) & Webinar Bundle
This work instruction provides detailed instructions for a security incident response to a cybersecurity incident. The work instruction utilizes Medical Device Academy’s CAPA report form (FRM-009). Each section of the CAPA report form is filled in to provide guidance on the information that should be entered in the CAPA report form for a security incident response plan. The procedure complies with the 2023 Guidance from the FDA on the cybersecurity of device pre-market submissions.
When is the webinar about this security incident response work instruction?
This webinar was recorded on Saturday, April 6, 2024. You can purchase it on-demand and watch the training as often as you wish.
What you will receive:
A template for a service record and a service log are included with the procedure. FRM-008 is also included with this procedure because when a product is returned for service, it should be treated as non-conforming material and segregated from the released product. These documents are updated for ISO 13485:2016 and the new European Regulations. The following is a list of documents included:
- WI-008 Security Incident Response
- FRM-059, Security Incident Investigation Report
- FRM-009, CAPA Report (for Security Incidence Response)
- Native Slide Deck for Training Webinar (22 slides)
- Recording of Training Webinar (April 6, 2024; 39 minutes)
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
This procedure utilizes Medical Device Academy’s CAPA form. Please visit our CAPA procedure webpage for more information. This procedure also references our cybersecurity work instruction (WI-007).
About the Speaker
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. His favorite part of his job is training others. He can be reached via phone 802.258.1881 or by email. You can also follow him on YouTube, LinkedIn or Twitter.
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