FREE! Pack of 7 Interesting Medical Device Webinar Recordings

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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