New Webinars are Coming Soon (or in progress)
- Vol 15 – Biocompatibility – $79 (Live on September 27, 2023 Updated Content)
- Cybersecurity Webinar – Free (Live on September 27, 2023 Updated Content)
Please submit comments to the FDA regarding the new FDA draft guidance on best practices for predicate selection
On September 13, 2023, we prepared a blog discussing the new FDA draft guidance for predicate selection best practices. We have specific recommendations for changes to this draft guidance. We want to encourage others to voice their opinions as well. Therefore, we are providing several links for you on our Predicate Selection Webinar page. The deadline for submission of comments is December 6, 2023 @ 11:59 pm EST.
Our latest YouTube short.
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 Friday @ 12:30 pm EDT (September 29, 2023).
In the next live-streaming YouTube video, we will answer the question “How to do a labeling review?”
This Friday (September 29th – no live-streaming on 9/22 due to website problems) you will learn how to do a labeling review. Specifically, we will use a special controls guidance document for an in vitro diagnostic device that is over-the-counter (OTC), and we will use real product labeling for a product already on the market.
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.
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:
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.
- Predicate Selection Webinar – $64.50
- Auditing MDSAP and QSR 4-part Webinar Series – $299
- Risk Management Training Webinar for ISO 14971:2019 – $129
- ISO/TR 24971:2020 Guidance on the application of risk management – $129
- 510k Course – $1,195
- EU MDR Regulation Webinar Series (8-part series) – $825
- De Novo Application Webinar, Updated for FY 2019 – $49
- FDA Pre-Sub Meetings – $129
- ISO 13485 – need training? – Stage 1 & 2 training webinars – for $258
- 21 CFR 820 Training Webinar (Updated 2019) – for $64.50
- CE Marking to UK Market Webinar – for $129
- Technical File Auditing for Compliance with MDR – $129
- How to write Instructions for Use (IFU) Webinar – $129
- Design Change Webinar (Updated for 2022) – $129
- Post-Market Surveillance Summary Report Webinar – $129
- FDA Inspection Webinar & FDA Inspection Work Instruction (WI-009) – $299
- Remote & Supplier Auditing – $129
- How to Create a Risk-Based CAPA Process – $129
- How to qualify your suppliers webinar – $129
- How to audit using the process approach – $129
- Small Business Qualification Webinar – $19
- Canadian Device Licensing Webinar – $49
- IFU Validation and PMS Webinar – $49
- In Vitro Diagnostics (IVD) 510k Webinar – $29
- Clinical Evaluation Report Procedure & Webinar Bundle – $299
- Performance Testing Webinar – $49
- FDA Declaration of Conformity (Form 3654) Webinar – $49
- New European Medical Device Regulations Webinar – $129
- Medical Device Reporting Webinar Bundle – 2 Live Recordings & Procedure for $299
- Control of Nonconforming Product Webinar Bundle – 2 Live Recordings & Procedure for $299
- Design History File (DHF) Webinar – (available on YouTube now)
- Death of design FMEA – $129
- Combining Product Risk Management with Design Controls – $129
- Process Validation: Avoiding Nonconformities, Complaints, FDA 483s and Recalls – $129
- Bioburden Failure Analysis: How auditors can investigate spikes in environmental monitoring – $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
- Good Documentation Practices “GDP 101” – $129
- 7 Steps to Respond to an FDA 483 Inspection Observation – $129
- FDA Medical Device Recalls, Labeling, and 21 CFR 820.120 – $129
- Complaint Handling and Vigilance Reporting – $129
- How to audit using the process approach (a.k.a – turtle diagrams) – $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
- Health Canada Medical Device Regulations & CMDCAS Requirements – $129
- 510k Summary Webinar – $79
Free Download Webinars (Don’t forget to subscribe to our YouTube Channel)
- What is a CE Mark and how to you apply for certification? – Free
- FDA eSTAR Draft Guidance Webinar – Free
- Cybersecurity Webinar – Free
- 510k Project Management Lessons Learned 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
- Special 510k Submission Webinar – Free if you ask a question
- 510k Pre-submission Webinar – Free if you submit a question
- Traceability Matrix Webinar – Free if you submit a question
- FDA eCopy Print & Ship Webinar – Free if you submit a question
- IEC 60601 Standards Status Update Webinar – Free if you submit a question
- 510(k) Best Practices: Combining Risk and Design Controls – Free if you submit a question
- Factory-CRO Clinical Study Webinar – Free if you submit a question
- How to complete Section 6, 7 and 8 of a 510(k) Submission – Free if you submit a question
- 510k FAQs 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