Risk Management Principles and Requirements – ISO14971 and IEC62304 Seminar 2018

Start Date : June 14, 2018
End Date : June 15, 2018
Time : 9:00 am to6:00 pm

Phone : 800-447-9407
Email : globalcompliancepanel@gmail.com

Location :
Four Points by Sheraton Boston Logan Airport Revere, MA 407 Squire Rd, Revere, Massachusetts 02151, United States

Website

Description

Course "Applying ISO14971 and IEC62304 - A guide to practical Risk Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


 


Overview:


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.


The course will emphasize the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management as well as the increasingly important software and usability related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden. To make the combines effort to design, implement and verify a safe device transparent the concept of an assurance case will be introduced.


The course is mainly based on international consensus requirements such as ISO14971, IEC62366 and IEC62304. It will cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner's perspective.


Following personnel will benefit from the course:



 


Agenda:


 





Lecture 2:


Risk Management to ISO 14971:2012



Day 2 Schedule




Lecture 1:


Usability and Risk Management





Lecture 2:


Software Risk Management (IEC62304 / FDA software reviewers' guidance):





Lecture 3:


Software Risk Management (IEC62304 / FDA software reviewers' guidance):





Lecture 4:


Safety / Assurance case



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:  Boston, MA  Date: June 14th & 15th, 2018 and Time: 9:00 AM to 6:00 PM


Venue:  Four Points by Sheraton Boston Logan Airport Revere, MA 407 Squire Rd, Revere, Massachusetts 02151, United States


 


Price:


Price: $1,295.00 (Seminar Fee for One Delegate)


 Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*


 Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*


 Register now and save $200. (Early Bird)


Until May 10, Early Bird Price: $1,295.00 From May 11 to June 12, Regular Price: $1,495.00


Sponsorship Program benefits for “Applying ISO14971 and IEC62304” 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/control/globalseminars/~product_id=901732SEMINAR?SEO


 


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Registration Info

https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901732SEMINAR?meetings4docs_june_2018_seo

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC DBA GlobalCompliancePanel ,
161 Mission Falls Lane,suite 216

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.

Tel: 8004479407
Mobile: 8004479407
Email: globalcompliancepanel@gmail.com
Website: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901732SEMINAR?meetings4docs_june_2018_seo


Event Categories: Health & Nutrition and Physical Medicine.




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