Update on new, more demanding Human Factors Guidances

for the Biomedical Industry
FDA and international standards
IEC 62366-1:2015 and IEC TR 62366-2:2016

תאריך: 4, 5 דצמבר 2017
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות:  09:00-17:00
עלות: 4,300 ש"ח + מע"מ
נקודות זכות: 2
מק''ט: 17802
שפת הקורס: אנגלית
על הקורס
Be prepared for the new and more demanding regulatory guidance and standards in human factors!
This course is an in-depth and comprehensive coverage of the latest regulatory guidances and standards that are all increasing expectations for the quality of human factors HF studies for medical products. These apply to medical devices, drug products and combination products in the USA (FDA and AAMI), EU (IEC and ISO) and the UK MHRA. All of these regulators have recently made significant changes in the level of quality and rigor expected in human factors studies supporting submissions for new medical products. The instructor, who is well known internationally for being a leader in the development of these standards, will describe each one and explain what is required. He will cover the challenges for regulatory compliance, as well as giving practical advice on HF methods suitable for manufacturers in following these guidances and standards.
קהל היעד
  • Product Design Engineers including software and hardware
  • Quality and Regulatory Personnel
  • Product Marketing
  • Medical Affairs
  • Packaging and Labeling designers

Update on new, more demanding Human Factors Guidances
התועלת שתופק

Reason’s to Attend

  • Know the new FDA regulatory expectations for human factors/usability for all medical product approval
  • Understand what is required internationally for medical product approval including devices, combination products and drug packaging and labeling
  • Learn about practical issues in applying the large list of HF/UE standards and regulations including many that are not as well knows such as standards for symbols, alarms, connectors, instructions, packaging and labeling from a highly experienced instructor who has both practiced HF/UE for over 40 years and who leads HF standards work with the US FDA and other international regulators.
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
Guidances and Standards covered:

  • FDA CDRH final guidance on medical devices: Applying Human Factors and Usability Engineering to Medical Devices: Feb  2016
  • FDA DRAFT Guidance on:  List of Highest Priority Devices for Human Factors Review: 2016
  • FDA DRAFT Guidance from CDER/CBER/CDRH on: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development: 2016
  • FDA CDER final Guidance: Safety Considerations for Product Design to Minimize Medication Errors, April 2016
  • FDA DRAFT Guidances from CDER on Container Closure Labeling and Drug Naming
  • IEC 62366-1: 2015 Medical devices – Part 1: Application of usability engineering to medical devices
  • IEC/TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
  • IEC TR 60878:2015 Graphical Symbols For Electrical Equipment In Medical Practice
  • AAMI TIR 50:2014 Post-market surveillance of use error management
  • AAMI TIR 51:2014 Human factors engineering – Guidance for contextual inquiry
  • AAMI TIR 59:2017  DRAFT- Integrating human factors into design controls
  • AAMI HE-75 Ed 2:2017  DRAFT Human factors engineering – Design of Medical Devices
  • UK MHRA DRAFT Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products, June 2016
Other standards:
  • IEC 62366-1: 2015:  Medical devices – Part 1: Application of usability engineering to medical devices- DRAFT Amendment 1:2017 and Corrigendum 2016
  • Amendment 1 to IEC 60601-1-6: 2014 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: General requirement for basic safety and essential performance – Collateral standard: Usability
  • IEC 60601-1-6:2010: Amendment 2:2017 DRAFT
אודות המרצה

Dr. Edmond Israelski

Edmond Israelski is director of human factors at Abbott, a medical device and pharmaceutical company. He joined Abbott in 2001, where he leads a cross-division team to imbed best-practice human factors HF design methods into all of Abbott's products, to ensure safety and usability.
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