New Webinars are Coming Soon (or in progress)
- Special 510(k) Webinar – $79 – Live Webinar @ 10:30 am ET March 28, 2024
- Distribution Procedure (SYS-015) & Webinar Bundle – $299 – Live Webinar @ 10:30 am ET April 1, 2024
- Security Incident Response Policy (WI-008) & Webinar Bundle – $299 – Live Webinar @ 10:30 am ET April 4, 2024
- Software Tool Validation Procedure (SYS-051) & Webinar Bundle – $299 – Live Webinar @ 10:30 am ET April 8, 2024 (Mary Vater)
- Cybersecurity Work Instruction (WI-007) & Webinar Bundle – $399 – Live Webinar @ 10:30 am ET April 11, 2024 (Bhoomika Joyappa)
- Supplier Quality Management Procedure (SYS-011) & Webinar Bundle – $299 – Live Webinar @ 10:30 am ET April 15, 2024
- Use Specification Template & Webinar Bundle – $79 – Recorded Webinar available April 18, 2024
- Facility, Plant, and Equipment Maintenance Procedure & Webinar Bundle – $299 – Live Webinar @ 10:30 am ET April 22, 2024
- Sterilization Validation Webinar – $79 – Live Webinar @ 10:30 am ET April 25, 2024
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Our latest YouTube short.
Weekly Live-Streaming Topics
Below is a countdown clock for our next live-stream YouTube video and the schedule for the new live webinars we are hosting. Our next YouTube Live-streaming video will be on Friday @ 12:30 pm ET (March 29, 2024). In the next live-streaming YouTube video, we will discuss “Should you use your CAPA form and CAPA log to document cybersecurity incident responses? or should you have a separate form and log for that purpose?”
Human Factors Webinars
- Formative Usability Testing Webinar & Template Bundle – $79
- Use Specification Template & Webinar Bundle – $79 – Recorded Webinar available April 18, 2024
- Known Use Error & Database Search Template & Webinar Bundle – $129 – Later this year
- Task Analysis Template & Webinar Bundle – $129 – Later this year
- Use-Related Risk Analysis (URRA) Template & Webinar Bundle – $199 – Later this year
- Summative Usability Testing Protocol & Webinar Bundle – $199 – Later this year
- Summative Usability Testing Report & Webinar Bundle – $79 – Later this year
Risk Management Webinars
- Auditing Risk Management Files – $64.50
- Risk Management Training Webinar for ISO 14971:2019 – $129
- ISO/TR 24971:2020 Guidance on the application of risk management – $129
Design Controls Webinars
- Design Controls Webinar (Updated for 2023) – $129
- Design Change Webinar (Updated for 2022) – $129
- Design History File (DHF) Webinar – (available on YouTube now)
- Combining Product Risk Management with Design Controls – $129
Quality System Webinars
- ISO 13485 – need training? – Stage 1 & 2 training webinars – for $258
- 21 CFR 820 Training Webinar (new QMSR) – $79
- How to Create a Risk-Based CAPA Process – $129
- How to qualify your suppliers – $129
- Good Documentation Practices “GDP 101” – $129
- Complaint Handling and Vigilance Reporting – $129
Auditing Webinars
- Auditing MDSAP and QSR 4-part Webinar Series – $299
- Remote & Supplier Auditing – $129
- How to audit using the process approach – $129
MISC Webinars
- How to write Instructions for Use (IFU) Webinar – $129
- Post-Market Surveillance Summary Report Webinar – $129
- IFU Validation and PMS Webinar – $49
- Process Validation: Avoiding Nonconformities, Complaints, FDA 483s and Recalls – $129
- Bioburden Failure Analysis: How auditors can investigate spikes in environmental monitoring – $129
- 7 Steps to Respond to an FDA 483 Inspection Observation – $129
- FDA Medical Device Recalls, Labeling, and 21 CFR 820.120 – $129
CE Marking Webinars
- EU MDR Regulation Webinar Series (8-part series) – $825
- CE Marking to UK Market Webinar – for $129
- Technical File Auditing for Compliance with MDR – $129
- FDA Declaration of Conformity (Form 3654) Webinar – $49
- New European Medical Device Regulations Webinar – $129
- Notified Body Unannounced Audit: A Roadmap for Successful Preparation – $64.50
- Preparing for the New Post Market Clinical Follow Up (PMCF) Requirements – updated for Regulation (EU) 2017/745 – $129
- Preparing for New Technical File and Design Dossier Requirements: How to Convert a Class IIb Technical File to a Class III Design Dossier – $129
Canadian Medical Device Licensing Webinars
- Canadian Device Licensing Webinar – $49
- Health Canada Medical Device Regulations & CMDCAS Requirements – $129
If you want to be notified of new webinars another way, including the paid webinars that we do not post on our YouTube channel, please subscribe to our email webinar notification list using the form below:
In addition to the webinars available for purchase on this page, you can also watch videos that we have posted on our YouTube channel. If you are a channel subscriber, you will receive automatic notifications of new YouTube postings on our channel by clicking on the notification bell. The time remaining until our YouTube live-streaming video is shown below, and please don’t forget to email Rob your questions at rob@13485cert.com.
The following is a list of quality and regulatory training webinars that are available for on-demand purchase from this website. If you subscribe to our email notification list using the form on the right, we will notify you by email of any new webinars when we add them to this page. You can also suggest new topics by submitting your idea to the Suggestion Box.
Free Webinars (Don’t forget to subscribe to our YouTube Channel)
- What is a CE Mark and how to you apply for certification? – Free
- Cybersecurity Webinar – Free
- Interview with Aaron Moncur – Test Fixture Design – Free
- Interview with Rick Stockton: How to Manage Your a Design FMEA – Free
- Management Review Webinar: Making Your Meetings More Effective – Free
- Create an ISO 13485 Quality Plan – Free
- Audit team communication during a remote audit – Free
- Opening Meetings Webinar – Free if you submit a question
- Is Your Medical Device Startup Missing Out on the R&D Tax Credit? – Free
- Post-Market Clinical Follow-up (PMCF) Mobile App – Free if you submit a question
- 513g Request Webinar – Free downloads with templates
- Human Factors Testing Webinar – Free if you submit a question
- Traceability Matrix Webinar – Free if you submit a question
- IEC 60601 Standards Status Update Webinar – Free if you submit a question
- Combining Risk and Design Controls – Free if you submit a question
- Factory-CRO Clinical Study Webinar – Free if you submit a question
- How To Perform A CAPA Effectiveness Check and 5 Tools for Root Cause Analysis – Free Download
- 6 Steps to ISO 13485 Certification – Free Download
- Management Review Webinar: Making Your Meetings More Effective – Free Download
- FDA UDI Regulation’s Impact on Medical Device Labelers – Free Download
- MDSAP QMS update webinar to meet country-specific requirements – Free Download