A guide to practical Risk Management - Applying ISO14971 and IEC62304

  • 2000.00 Dollar US$
  • Published date: May 14, 2019
    • Philadelphia, Pennsylvania, United States

Description:
Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.
To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.
Who Will Benefit:
The course will introduce the main elements of risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management being a mandatory component of almost any activity in the medical device industry.
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Project managers
• Design engineers
• Software engineers
• Process owners
• Quality engineers
• Quality auditors
• Medical affairs
• Legal Professionals

Speaker:
Markus Weber
Principal Consultant, System Safety Inc.
Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.

Location: Philadelphia, PA Date: October 3rd and 4th, 2019 and Time 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON

Price:
1 ATTENDEE $2,000, Regular Price: $2000, Register for 1 attendee
5 ATTENDEES $10,000, Regular Price: $10,000, Register for 5 attendees
10 ATTENDEES $20,000, Regular Price: $20,000, Register for 10 attendees
Until August 20, Early Bird Price: $2,000. From August 21 to October 01, Regular Price: $2,200.
Use this promo code GCP50 to get 50% off.

Sponsorship Program benefits for seminar
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link - https://www.globalcompliancepanel.com/seminar/applying-ISO-practical-risk-management-901963SEMINAR?seo
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

Result 0 votes
John Robinson
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • PHP Frameworks Guide & Top 10 Best PHP Framework 2019

    PHP Frameworks Guide & Top 10 Best PHP Framework 2019

    Training and Teaching Albama (Albama) July 15, 2019 Check with publisher

    PHP is used by almost 83% of websites across the world and is thus one of the widely used languages for web design and development throughout the world. Rasmond Lerdoff did not develop it as a programming language. It originated simply to manage his ...

  • 3 Components of Java Programming Language

    3 Components of Java Programming Language

    Training and Teaching Albama (Albama) July 10, 2019 Check with publisher

    Computer programming is a continuous and fastest changing arena. One of the purpose of programming is to find a solution to a problem in a typical way. Programmers always need to stay relevant and address new challenges, besides having a very good pr...

  • Texting and E-mail with Patients - Meeting Patient Requests within the HIPAA Rules

    Texting and E-mail with Patients - Meeting Patient Requests within the HIPAA Rules

    Training and Teaching Fremont (California) July 3, 2019 545.00 Dollar US$

    E-mail has long been a staple of people's lives, but as we move into the new digital age, it seems everyone is moving to a new smart phone and wants to use it in all the incredible ways it can be used for health care purposes, including the use of e-...