Medical Device Software Process Blackbelt

Master the 62304 standard and FDA design controls

What you'll learn

Learning the Medical Device Software Process

Medical Device Software Regulatory Insights

Mastering the IEC 62304 Standard

ISO 14971 and Risk Management

Safety Critical Software Fundamentals

SiMD and SaMD

FDA and Design Controls

Cybersecurity and Premarket Submissions

Use of Static Analysis for Medical Device Software

Requirements

None

Description

DescriptionThe ultimate course for mastery of the medical device software process. This course gives you access to 5 hours of training from an industry expert covering safety critical software principles, FDA design controls, the latest FDA draft guidance documents, and deep insight into IEC 62304 and ISO 14971 international standards. You will graduate a blackbelt and walk away with confidence.Often people have fragments of the medical device process in their head but have never been able to put all of the pieces of the puzzle together. This course is unique and comes to the rescue because the training was put together by a software expert who has done the hands-on work and regulatory submissions for Class III implantable medical devices for 16 years.  Why spend thousands of dollars elsewhere? You are invited to spend 11 minutes watching the preview video which will explain why you should take this course!Some HighlightsIEC 62304 in depthISO 14971 and software risk managementSoftware Safety ClassificationAll phases of the software development lifecycle: Planning, Requirements, Design, Testing, and ReleaseSoftware MaintenanceConfiguration ManagementProblem ResolutionSiMD and SaMDLate breaking FDA draft cybersecurity requirementsLate breaking FDA draft premarket submission requirementsStatic AnalysisCoding StandardsLifetime AccessMaterialsPDFs of all slides for all lecturesA white paper on static analysis for medical device software62304 checklists

Overview

Section 1: Introduction

Lecture 1 Why Take This Course?

Lecture 2 Safety Critical Foundation

Section 2: Standards

Lecture 3 The Medical Device Standards

Section 3: Regulatory Insights

Lecture 4 Regulatory Overview & FDA

Section 4: Quality Systems and Design Controls

Lecture 5 Design Controls per United States and FDA

Section 5: Medical Device Software Process - Risk Fundamentals

Lecture 6 Overview

Lecture 7 Quality System

Lecture 8 Risk Managment Intro

Lecture 9 Software Safety Classification

Lecture 10 Legacy Software

Lecture 11 Software Risk Management

Section 6: Medical Device Software Process - The SDLC

Lecture 12 Software Planning

Lecture 13 Software Requirements Analysis

Lecture 14 Software Architectural Design

Lecture 15 Software Detailed Design

Lecture 16 Software Implementation & Unit Testing

Lecture 17 Software Integration & Testing

Lecture 18 Software System Testing

Lecture 19 Software Release

Section 7: Medical Device Software Process - Other

Lecture 20 Software Maintenance

Lecture 21 Software Configuration Management

Lecture 22 Software Problem Resolution

Section 8: Miscellaneous

Lecture 23 FDA Cybersecurity Draft Guidance

Lecture 24 FDA Premarket Software Functions Draft Guidance

Lecture 25 Static Analysis and Medical Device Software

Anyone who wants to learn about the medical device software development process,Anyone who wants to master IEC 62304,Anyone who wants to know more about software risk control and ISO 14971,Anyone who wants to know more about safety critical systems,Anyone who wants to learn more about FDA expectations for software,Anyone who wants to be a better software engineer