Applying ISO14971 and IEC62304 – A guide to practical Risk Management 2018

Start Date : January 29, 2018
End Date : January 30, 2018
Time : 9:00 am to6:00 pm

Phone : 800-447-9407
Email : john.robinson@globalcompliancepanel.com

Location :
DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153

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:

 

Day 1 Schedule

 

Lecture 1:

Introduction into Risk Management and Quality System Integration

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: Philadelphia, PADate:  January 29th & 30th, 2018 and Time: 9:00 AM to 6:00 PM

Venue: DoubleTree by Hilton Philadelphia Airport   4509 Island Avenue, Philadelphia, PA 19153

 

Price:

 

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

Register now and save $200. (Early Bird)

Until December 15, Early Bird Price: $1,295.00 From December 16 to January 27, Regular Price: $1,495.00

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%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Informationhttps://www.globalcompliancepanel.com/control/sponsorship 

 

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Registration Info

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901453SEMINAR?meetings4docs-January-2018-SEO

 

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Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous DBA as GlobalCompliancePanel ,
NetZealous LLC-GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont,CA 94539, USA

Tel: Event Manager
Mobile: 800-447-9407
Email: john.robinson@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com/


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