Medical Device Software Development & Management - Comprehensive Training Package (4 Courses)

This Medical Device Software Development & Management package training will have 4 courses which covers FDA's Medical Device Software Regulation, Medical Device Software Verification and Validation, IQ / OQ / PQ Approach and IEC 62304.

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All Modules:

Module 1: FDA's Medical Device Software Regulation
Module 2: Medical Device Software Verification and Validation
Module 3: Using an IQ / OQ / PQ Approach to Validating Medical Device Software
Module 4: Aligning Medical Device Software Development with EU Requirements for a CE Mark (IEC 62304)

Module 1 : FDA's Medical Device Software Regulation - (Last Recorded Date: Jun-2016)

Areas Covered in the Webinar:

• FDA software guidance
• National Institute of Science and Technology guidance reports
• Cybersecurity
• Interoperability
• Mobile apps
• Software validation
• Software recalls

Instructor Profile:

Casper Uldriks brings over 32 years of experience from the FDA. He specializes in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an associate center director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Mr. Uldriks is the president of Encore Insight, LLC, a consulting service for FDA matters.

Module 2 : Medical Device Software Verification and Validation - (Last Recorded Date: Aug-2017)

Areas Covered in the Webinar:

• Basic Introduction to 62304
• Level of Concern
• High Level Risk Management
• Medical Device Software User Requirements
• Medical Software Device System Requirements
• Medical Device Software V Model
• Software Requirements
• Software Architecture
• Software Design
• SOUP
• Unit Testing
• Integration Testing

Instructor Profile:

Nancy Knettell, Founder and Principal at Signet Medical Systems, LLC, has over 30 years in combined mechanical design, software development, and systems engineering experience primarily in the medical device industry as a Software Verification, Validation/Systems Engineer.

Module 3 : Using an IQ / OQ / PQ Approach to Validating Medical Device Software - (Last Recorded Date: Jun-2016)

Areas Covered in the Webinar:

• Development of software test plans.
• How to apply IQ / OQ and PQ techniques to software?
• Risk based software testing.
• How does Software Validation relate to Design Validation?
• Typical software tests.
• What is the appropriate sample size for software testing?
• Software issue tracking.
• How to address open issues when releasing software.

Instructor Profile:

Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over twenty-five years of experience in the Medical Device industry. Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems.

Module 4 : Aligning Medical Device Software Development with EU Requirements for a CE Mark (IEC 62304) - (Last Recorded Date: Feb-2014)

Areas Covered in the Webinar:

• An overview of IEC 62304 requirements for software development processes
• The alignment of the IEC 62304 requirements with FDA and ISO 13485 design control requirements
• The alignment of IEC 62304 deliverables with requirements for the content of FDA submissions for software in medical devices
• Path to IEC 62304 compliance
• Modifying existing software development processes to comply with IEC 62304
• Implementation pitfalls
• Success factors in achieving IEC 62304 compliance with outsourced software development
• Questions and answers

Instructor Profile:

Dr. Tim Stein, Ph.D. is the President and CEO of Business Performance Associates, Inc., a consulting firm located in Cupertino, California, that he founded in 1994. Tim's has provided service to over 100 clients in software development processes, quality systems, and computer system validations. Tim also served as the Director of Software Validation and Quality Assurance at Genomic Health, Inc. (GHI).

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