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Fundamentals of EU MDR and IVDR – Level 1

 
  May 20, 2021  
     
 
ComplianceOnline, Virtual Training Through WebEx
24/6/21



DAY 01(8:00 AM - 2:00 PM PDT)
  • Introduction/review of Medical Device Regulation and timeline
  • Differences between the old and new version (MDD/MDR)
  • Lifecycle of a Device, Process pre and post market
  • Transitioning to the new requirements
DAY 02(8:00 AM - 2:00 PM PDT)
  • Compliance procedures and Quality Management Systems
  • General safety and performance (GSPR) and Common Specifications (CS)
  • Integrating ISO 13485:2016; UDI; Technical file requirements
  • Preparing a Gap Assessment, Transitioning to MDR, and Understanding EUDAMED
DAY 01(8:00 AM - 2:00 PM PDT)
  • Introduction/review of Medical Device Regulation and timeline
  • Differences between the old and new version (MDD/MDR)
  • Lifecycle of a Device, Process pre and post market
  • Transitioning to the new requirements
DAY 02(8:00 AM - 2:00 PM PDT)
  • Compliance procedures and Quality Management Systems
  • General safety and performance (GSPR) and Common Specifications (CS)
  • Integrating ISO 13485:2016; UDI; Technical file requirements
  • Preparing a Gap Assessment, Transitioning to MDR, and Understanding EUDAMED
DAY 01(8:00 AM - 2:00 PM PDT)
  • Introduction/review of Medical Device Regulation and timeline
  • Differences between the old and new version (MDD/MDR)
  • Lifecycle of a Device, Process pre and post market
  • Transitioning to the new requirements
DAY 02(8:00 AM - 2:00 PM PDT)
  • Compliance procedures and Quality Management Systems
  • General safety and performance (GSPR) and Common Specifications (CS)
  • Integrating ISO 13485:2016; UDI; Technical file requirements
  • Preparing a Gap Assessment, Transitioning to MDR, and Understanding EUDAMED
DAY 01(8:00 AM - 2:00 PM PDT)
  • Introduction/review of Medical Device Regulation and timeline
  • Differences between the old and new version (MDD/MDR)
  • Lifecycle of a Device, Process pre and post market
  • Transitioning to the new requirements
DAY 02(8:00 AM - 2:00 PM PDT)
  • Compliance procedures and Quality Management Systems
  • General safety and performance (GSPR) and Common Specifications (CS)
  • Integrating ISO 13485:2016; UDI; Technical file requirements
  • Preparing a Gap Assessment, Transitioning to MDR, and Understanding EUDAMED
DAY 01(8:00 AM - 2:00 PM PDT)
  • Introduction/review of Medical Device Regulation and timeline
  • Differences between the old and new version (MDD/MDR)
  • Lifecycle of a Device, Process pre and post market
  • Transitioning to the new requirements
DAY 02(8:00 AM - 2:00 PM PDT)
  • Compliance procedures and Quality Management Systems
  • General safety and performance (GSPR) and Common Specifications (CS)
  • Integrating ISO 13485:2016; UDI; Technical file requirements
  • Preparing a Gap Assessment, Transitioning to MDR, and Understanding EUDAMED
DAY 01(8:00 AM - 2:00 PM PDT)
  • Introduction/review of Medical Device Regulation and timeline
  • Differences between the old and new version (MDD/MDR)
  • Lifecycle of a Device, Process pre and post market
  • Transitioning to the new requirements
DAY 02(8:00 AM - 2:00 PM PDT)
  • Compliance procedures and Quality Management Systems
  • General safety and performance (GSPR) and Common Specifications (CS)
  • Integrating ISO 13485:2016; UDI; Technical file requirements
  • Preparing a Gap Assessment, Transitioning to MDR, and Understanding EUDAMED
 
 
Organized by: ComplianceOnline
Invited Speakers:

Ms. Eisenhardt is Co-Founder and Managing Director at BlueCircle Advisors LLC, a consulting firm providing strategy and programming to address the global challenges of product compliance, business continuity, and supply chain risk management.

Her company’s mission is to protect corporate revenues by building product and supply chain compliance programs that meet global requirements, provide the necessary due diligence to maintain and secure new business, and to train the next generation of managers in the compliance field. She is currently working with clients in the electronics, aerospace & defense, plastics, and medical device industries to implement compliance programs for regulations like EU MDD/MDR, RoHS, REACH, Conflict Minerals, supplier code of conduct, and anti-trafficking.

With 20 years’ experience in IT and Compliance Software Development, her former roles include: Executive Director of Environmental Programs, at Fair Factories Clearinghouse; Environmental Compliance Manager and Design for Environment programs at EMC/Dell Corporation; and Director of Product Management at PTC Corporation for Windchill Product Analytics – an environmental compliance software.

She is also a journalist for industry trade publications such as 3BL, JustMeans, Social Earth, CSRwire, Ethical Performance, and CSR@Risk with a focus on trends in product compliance, supply chain transparency, and corporate social responsibility.

She currently is the host of the BlueCircle Advisors Hour, a radio show on WCRN broadcast along the east coast of the United States and accessible via internet radio stations like Tunein.com. The radio show discusses product compliance topics of interest and includes interviews with leaders in the compliance and technology fields. Podcasts will be available on iTunes, Google Play Store, Stitcher, and more in early September 2019.

 
Deadline for Abstracts: 24/6/21
 
Registration:
$1,499*
(Seminar for One Registration)
June 24-25, 2021, Virtual Seminar

Register now and save $400 (Actual Price: $1,899)

E-mail: referral@complianceonline.com
 
   
 
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