FREE! Pack of 7 Interesting Medical Device Webinar Recordings

Product ID: 705569

recorded version

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Read Frequently Asked Questions

All Modules:

Module 1: Webinar: When Do You Need a 510K?
Module 2: ISO 14971:2007 and the CE-Mark
Module 3: Failure Investigation and Root Cause Analysis - Simple Tools, Powerful Results
Module 4: What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Documents Explained
Module 5: Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge
Module 6: Fault Tree Analysis: A Risk Management Tool
Module 7: ISO 13485 and medical device quality systems - practical strategies for planning, implementation and beyond

Module 1 : Webinar: When Do You Need a 510K?

Areas Covered in the Webinar:

  • 510K submission.
  • Premarket Approval submission.
  • History of the 510k since it was initially created in 1976.
  • When between a PMA and 510k, submitting a 510K is appropriate?
  • PMA versus a 510K - time and cost factors.
  • Failure to submit a 510K - individual(s) responsibility, corporate responsibility, criminal prosecution and penalties.
  • Civil penalty, civil action and injunction action.
  • When not to file a 510K in Class I and Class II devices.
  • Managing FDA inspection when 510K is not files.

Module 2 : ISO 14971:2007 and the CE-Mark

Areas Covered in the Webinar:

  • Key requirements of ISO 14971; ICH Q9.
  • Suggested formats.
  • Expected sources of information to evaluate.
  • What to include.
  • How to complete, document, and control.
  • An often neglected safety feature.
  • A "living" useful, cost-saving document.

Module 3 : Failure Investigation and Root Cause Analysis - Simple Tools, Powerful Results

Areas Covered in the Webinar:

  • Importance of Formal Failure Investigation and Root Cause Analysis to CGMPs, ISO 13485, ISO 9001, ISO 14971, and quality improvement initiatives.
  • Accurate Event Description.
  • A Sample Failure Investigation Template.
  • 7 Powerful Tools for Root Cause Analysis.
  • Investigation Detail - Root or Probable Cause.
  • Impact -- Often neglected but of major importance.
  • Use in CAPA and Validation.
  • Effectiveness -- Determining and Monitoring.

Module 4 : What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Records Explained

Areas Covered in the Webinar:

  • FDA Quality Systems Regulations, documents and records.
  • The Product Development Life Cycle.
  • Design History File (DHF).
    • Definition.
    • Types of documents and records.
    • Examples.
    • DHF and design firms
    • DHF and outsourced designs
    • Ownership and control of DHF
  • Device Master Record (DMR).
    • Definition
    • Description and typical content of a DMR
    • DMR and outsourced design
    • DMR and outsourced production
    • Ownership and controls of DMR
    • Controlling and maintaining DMR
  • Device History Record (DHR)
    • Definition
    • Contents
    • Using the data and information in a DHR for monitoring, tracking and trending
    • DHR and outsourced production
    • Ownership and control of DHR
  • Design changes and DHF, DMR and DHR
  • Process changes and DHF, DMR and DHR
  • Examples of a DHF, DMR and DHR
  • Conclusion and best practices

Module 5 : Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge

Areas Covered in the Webinar:

  • FDA and ISO requirements for complaint handling.
  • Establishment of complaint handling program.
  • What constitutes a complaint.
  • ISO-specific implications of complaint handling.
  • The roles of investigation and corrective action in complaint handling.
  • Complaint trending and reporting.
  • Application of risk management to complaint handling program.

Module 6 : Fault Tree Analysis: A Risk Management Tool

Areas Covered in the Webinar:

  • History of Fault Tree Analysis.
  • Why all industries use it?
  • Fault Tree Analysis procedure.
  • Risk mitigation procedure.
  • Fault Tree symbols.
  • Fault Tree construction.
  • Assessing the effectiveness of the product design.
  • Calculating probability of harm.
  • Using FTA for design improvements.
  • Using FTA to assess the process vulnerability.
  • Using FTA for developing product validation tests.

Module 7 : QISO 13485 and medical device quality systems - practical strategies for planning, implementation and beyond

Areas Covered in the Webinar:

  • US, Canada and EU – know the requirements, build a single system.
  • Planning your quality system – what you need now, what should happen later, who should help.
  • Documentation – start from new, or build on what you have – make sure it works for your company.
  • Implementation – how to's.
  • Finding a registrar/Notified Body that will be a good fit for your company/scope/product(s)/budget – how to shop around and get the most from your investment; what to do if you aren't!
  • Got your certificate - now what?
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21 CFR Part 11 Compliance for SaaS/Cloud Applications
FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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