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Medical Devices Regulations News

Medical Device Electrical Safety (IEC 60601-1 3rd Edition)

Past event

Crowne Plaza 4290 El Camino Real, Palo Alto, CA 94306

About the training

With over one million certified companies over the world, the international Quality Management System standard ISO 13485 is among the most commonly used.

Since its first publication in 1993, several revisions have taken place aligning the standard with the evolution of the industry and the market needs. The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016.

Since its first publication in 1993, several revisions have taken place aligning the standard with the evolution of the industry and the market needs. The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016.

Since its first publication in 1993, several revisions have taken place aligning the standard with the evolution of the industry and the market needs. The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016.

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Jawad Mahdavi Medical Device Lead Auditor

Jawad Mahdavi is a senior medical device lead auditor. He brings to GMED North America with a reservoir of technical and regulatory knowledge through his various experiences from working in innovative and International environments.

Jawad holds various professional certifications, in addition to serving as a medical device lead auditor for GMED NA, Jawad routinely participates as a training instructor for regulations surrounding IVD devices.

Découvrez le programme

Day 1
08:09 - 09:00
Breakfast
09:00 - 00:00
Program
  • Regulation structure
  • Scope and Definitions
  • Actors and Responsibilities
  • Device Classification Criteria
  • Conformity Assessment routes
  • Quality Management System requirements
  • Technical Documentation
  • Post Market Surveillance and Vigilance
  • The Transition
12:00 - 14:00
Lunch
14:00 - 17:00
Program + Practice session
  • Practical working sessions
  • Group workshop
  • Course Evaluation
  • Summary and Discussion with the trainer
Day 2

Meet our Speakers

Our Regulatory and Technical Experts will be speaking at the following sessions:

Jane Doe | Clinical Data
Evaluator

PhD, Certification Project Manager IVD Product Assessor

Demystifying the EU MDR and IVDR: From Transition to Implementation.

Workshop | Monday,
October 1, 9:00 AM - 5:00 PM
Lire la biographie

Jane Doe | Clinical Data Evaluator

PhD, Certification Project Manager IVD Product Assessor

Demystifying the EU MDR and IVDR: From Transition to Implementation.

Workshop | Monday,
October 1, 9:00 AM - 5:00 PM
Lire la biographie
Jane Doe | Clinical Data <br>Evaluator photo

Jane Doe | Clinical Data
Evaluator

PhD, Certification Project Manager IVD Product Assessor

Demystifying the EU MDR and IVDR: From Transition to Implementation.

Workshop | Monday,
October 1, 9:00 AM - 5:00 PM

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Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.

Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.

Jane Doe | Clinical Data Evaluator photo

Jane Doe | Clinical Data Evaluator

PhD, Certification Project Manager IVD Product Assessor

Demystifying the EU MDR and IVDR: From Transition to Implementation.

Workshop | Monday,
October 1, 9:00 AM - 5:00 PM

Lorem Ipsum 2 is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.

Lorem Ipsum 2 is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.

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