and FDA Regulations
Software Development Practices and FDA Compliance
IEEE Orange County Computer Society March 27, 2006
Carl R. Wyrwa
2 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Medical Product Software Development and FDA Regulations Introduction
Regulated Software FDA Overview
Medical Device Definition Software – Special Attention Regulation Of Software
Basic Requirements Software Quality Model Software Safety Model Software Maintenance
Corrective Action and Preventive Action (CAPA) Reference Material
Conclusion
3
The Intent Of Regulating Software
Patients
Operators Bystanders Service
Personnel Environment
Medical Device Safety and Efficacy
4 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
People Doing
The Work
Reviewers Internal Auditors External Reviewers
Many Stakeholders – Keeping A Total Solution In Mind
Safety
Patients Operators Bystanders Service People
Environment Customer
and Business
Needs
Quality Systems
and Q&RA Medical Practitioners
All Needs
Met
5
People Doing
The Work
Reviewers Internal Auditors External Reviewers
Safety
Patients Operators Bystanders Service People
Environment Customer
and Business
Needs
Quality Systems
and Q&RA Medical Practitioners
All Needs
Met
6 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Introduction
Regulated Software FDA Overview
Medical Device Definition Software – Special Attention Regulation Of Software
Basic Requirements Software Quality Model Software Safety Model Software Maintenance
Corrective Action and Preventive Action (CAPA) Reference Material
Conclusion
Medical Product Software Development and FDA Regulations
7
Types of Regulated Software
Medical Device Software
z Software that is actually a part of the medical device itself
z Software that is an accessory to a medical device
z Software that itself is a medical
device
8 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Types of Regulated Software
Medical Device Software
z Software that is actually a part of the medical device itself
z Software that is an accessory to a medical device
z Software that itself is a medical device
Non-Device Software that is part of:
z The production system
z The quality system
z Systems that are used to create
and maintain records required
by FDA regulations
9
Introduction
Regulated Software FDA Overview
Medical Device Definition Software – Special Attention Regulation Of Software
Basic Requirements Software Quality Model Software Safety Model Software Maintenance
Corrective Action and Preventive Action (CAPA) Reference Material
Conclusion
Medical Product Software Development and FDA Regulations
10 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
FDA Overview
FDA is a public health agency, charged with:
z protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act and several related public health laws.
It is FDA's job to see that:
z the food we eat is safe and wholesome,
z the cosmetics we use won't hurt us,
z the medicines and medical devices we use are safe and effective,
z and that radiation-emitting products, such as microwave ovens, won't do us harm
z One of our nation's oldest consumer protection agencies.
z Located in district and local offices in 157 cities across the country
11
Medical Devices
32,358
12 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
FDA Overview
z Administrative Enforcement Powers
z
Unannounced and Announced Inspections
z
Inspectional Observations - 483
z
Warning Letters
z
Adverse Publicity
z
FDA-Initiated Recalls and Monitoring Company-Initiated Recalls
z
Delay, Suspension, or Withdrawal of Product Approvals
z
Preclusion of Government contracts
z
Detention and Refusal of Entry into U.S. Commerce of Imported Products
z Judicial Enforcement Powers
z
Civil Enforcement Powers (Seizure)
z
Criminal Enforcement Powers (Prosecution)
13
Introduction
Regulated Software FDA Overview
Medical Device Definition Software – Special Attention Regulation Of Software
Basic Requirements Software Quality Model Software Safety Model Software Maintenance
Corrective Action and Preventive Action (CAPA) Reference Material
Conclusion
Medical Product Software Development and FDA Regulations
14 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Medical Device Definition
z Medical devices range from
z Simple Devices
z Tongue depressors and bedpans
z Complex Devices
z Programmable pacemakers
z Laser surgical devices
z Medical Device Classification – Class I, II, and III
z Class I devices include those with the lowest risk
z Class III devices includes those with the greatest risk.
15
Medical Device Definition
• "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
• recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals,
• and which does not achieve any of it's primary intended purposes
through chemical action within or on the body of man or other animals
and which is not dependent upon being metabolized for the achievement
of any of its primary intended purposes."
16 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Introduction
Regulated Software FDA Overview
Medical Device Definition Software – Special Attention Regulation Of Software
Basic Requirements Software Quality Model Software Safety Model Software Maintenance
Corrective Action and Preventive Action (CAPA) Reference Material
Conclusion
Medical Product Software Development and FDA Regulations
17
820.30 Design Control
820.30(a) General
z (1) Each manufacturer of any class III or class II device,
and the class I devices listed in paragraph (a)(2) of this section, shall:
z establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
z (2) The following class I devices are subject to design controls:
(i) Devices automated with computer software; and
(ii) The devices listed ….. Below:
Catheter, Tracheobronchial Suction
Glove, Surgeon’s
Restraint, Protective
System, Applicator, Radionuclide, Manual
Source, Radionuclide Teletherapy
18 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Software – Special Attention
General Principles of Software Validation 3.3 Software Is Different From Hardware
z “Because of its complexity, the development process for software should be even more tightly controlled than for hardware, in order to prevent problems that cannot be easily detected later in the development
process”.
z “……. software engineering needs an even greater level of managerial scrutiny and control than does hardware engineering”.
[1]
19
Introduction
Regulated Software FDA Overview
Medical Device Definition Software – Special Attention Regulation Of Software
Basic Requirements Software Quality Model Software Safety Model Software Maintenance
Corrective Action and Preventive Action (CAPA) Reference Material
Conclusion
Medical Product Software Development and FDA Regulations
20 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Regulation of Software
21 CFR 807
Establishment Registration
21 CFR 807
Medical Device Listing
21 CFR 807
Premarket Notification 510(k)
21 CFR 820
Quality System Regulation
21 CFR 801
Labeling
21 CFR 803
Medical Device Reporting
21 CFR 814
Premarket Approval PMA Basic Regulatory
Requirements
21 CFR 820
Quality System Regulation
A - General Provisions B - Quality System
Requirements C – Design Controls D – Document Controls E – Purchasing Controls F – Identification
and Traceability G – Production & Process
Controls
H – Acceptance Activities I – Nonconforming Product J – Corrective & Preventive
Action (CAPA)
K – Labeling & Packaging Control
L – Handling, Storage,
Distribution & Installation M - Records
N - Servicing
O – Statistical Techniques
Quality System Regulation
C – Design Controls
820.30(a) General
820.30(b)
Design & Development Planning
820.30(c) Design Input
820.30(d) Design Output
820.30(e) Design Review
820.30(f) Design Verification
820.30(g) Design Validation
820.30(h) Design Transfer
820.30(i) Design Changes
820.30 (j) Design History File Design Controls
21
Regulation of Software
21 CFR 807
Establishment Registration
21 CFR 807
Medical Device Listing
21 CFR 807
Premarket Notification 510(k)
21 CFR 820
Quality System Regulation
21 CFR 801
Labeling
21 CFR 803
Medical Device Reporting
21 CFR 814
Premarket Approval PMA Basic Regulatory
Requirements
21 CFR 820
Quality System Regulation
A - General Provisions B - Quality System
Requirements C – Design Controls D – Document Controls E – Purchasing Controls F – Identification
and Traceability G – Production & Process
Controls
H – Acceptance Activities I – Nonconforming Product J – Corrective & Preventive
Action (CAPA)
K – Labeling & Packaging Control
L – Handling, Storage,
Distribution & Installation M - Records
N - Servicing
O – Statistical Techniques
Quality System Regulation
820.70(a) General
820.70(b)
Production & Process Changes
820.70(c) Environmental Control
820.70(d) Personnel
820.70(e) Contamination Control
820.70(f) Buildings
820.70(g) Equipment
820.70(h) Manufacturing Material
820.70(i) Automated Processes Production & Process Controls
G – Production & Process Controls
820.70(i) Automated Processes
22 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Regulation of Software
21 CFR 807
Establishment Registration
21 CFR 807
Medical Device Listing
21 CFR 807
Premarket Notification 510(k)
21 CFR 820
Quality System Regulation
21 CFR 801
Labeling
21 CFR 803
Medical Device Reporting
21 CFR 814
Premarket Approval PMA Basic Regulatory
Requirements
21 CFR 820
Quality System Regulation
A - General Provisions B - Quality System
Requirements C – Design Controls D – Document Controls E – Purchasing Controls F – Identification
and Traceability G – Production & Process
Controls
H – Acceptance Activities I – Nonconforming Product J – Corrective & Preventive
Action (CAPA)
K – Labeling & Packaging Control
L – Handling, Storage,
Distribution & Installation M - Records
N - Servicing
O – Statistical Techniques
Quality System Regulation
J – Corrective & Preventive
Action (CAPA) Corrective & Preventive Action820.100
Quality System
Requirements
23
Regulation of Software
21 CFR 807
Establishment Registration
21 CFR 807
Medical Device Listing
21 CFR 807
Premarket Notification 510(k)
21 CFR 820
Quality System Regulation
21 CFR 801
Labeling
21 CFR 803
Medical Device Reporting
21 CFR 814
Premarket Approval PMA Basic Regulatory
Requirements
21 CFR 820
Quality System Regulation
A - General Provisions B - Quality System
Requirements C – Design Controls D – Document Controls E – Purchasing Controls F – Identification
and Traceability G – Production & Process
Controls
H – Acceptance Activities I – Nonconforming Product J – Corrective & Preventive
Action (CAPA)
K – Labeling & Packaging Control
L – Handling, Storage,
Distribution & Installation M - Records
N - Servicing
O – Statistical Techniques
Quality System Regulation
B - Quality System Requirements
820.25(a) General 820.25(b)
Training
Quality System Requirements
820.22 Quality Audit
24 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Software Basic Requirements
A - General Provisions B - Quality System
Requirements C – Design Controls D – Document Controls E – Purchasing Controls F – Identification
and Traceability G – Production & Process
Controls
H – Acceptance Activities I – Nonconforming Product J – Corrective & Preventive
Action (CAPA)
K – Labeling & Packaging Control
L – Handling, Storage,
Distribution & Installation M - Records
N - Servicing
O – Statistical Techniques
Quality System Regulation
SW Risk/Hazard Analysis SW Human Factors (Use Errors) SW Change Control
SW Configuration Management SW Problem Tracking & Resolution SW Traceability
Non-Product Software Validation
Design Transfer Design History File Training
Software Quality Audits SW Architecture Verification
SW Detailed Design
SW Detailed Design Verification SW Coding
SW Code Verification Unit Test
Integration Test SW System Test Beta Testing SW Verification SW Validation
COTS Software Components Procedures
Plans
SW Life-Cycle Model SW Requirements Analysis SW Requirements Verification SW Architectural Design
Corrective & Preventive Action (CAPA)
25
Introduction
Regulated Software FDA Overview
Medical Device Definition Software – Special Attention Regulation Of Software
Basic Requirements Software Quality Model Software Safety Model Software Maintenance
Corrective Action and Preventive Action (CAPA) Reference Material
Conclusion
Medical Product Software Development and FDA Regulations
26 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Procedures and Plans
Procedures Plans
You must be able to demonstrate that you are
“Operating In A State Of Control”
Plans
Procedures +
• Establish, in advance of activities, what you are going to do.
• Do what you say you are going to do.
• Be able to provide objective (documented) evidence.
27
Software Development
SW Architecture Verification
SW Detailed Design
SW Detailed Design Verification
SW Coding
SW Code Verification SW Life-Cycle Model
SW Requirements Analysis SW Requirements Verification
SW Architectural Design
28 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Testing
Unit Test
Integration Test
SW System Test
Beta Testing
29
Verification & Validation
SW Verification
SW Validation
“Engineering Correctness Checks”
“Intended Use Confirmation”
30 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Supporting Processes
SW Risk/Hazard Analysis
SW Human Factors (Use Errors)
SW Change Control
SW Configuration Management SW Problem Tracking & Resolution SW Traceability
COTS Software Components
Non-Product Software Validation
Corrective and Preventive Action (CAPA)
31
Release
Design Transfer
Design History File
32 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Personnel
Training
Software Quality Audits
33
Introduction
Regulated Software FDA Overview
Medical Device Definition Software – Special Attention Regulation Of Software
Basic Requirements Software Quality Model Software Safety Model Software Maintenance
Corrective Action and Preventive Action (CAPA) Reference Material
Conclusion
Medical Product Software Development and FDA Regulations
34 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
The Reason
WHY
we need to have a comprehensive and effective Software Development Life Cycle
Software Quality and Software Safety
35
The Intent Of Regulating Software
Patients
Operators Bystanders Service
Personnel Environment
Medical Device Safety and Efficacy
36 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Understanding Defects
Start Development Process Ship
Defects
[2]
37
Understanding Defects
Start Development Process Ship
Defects
Defects Injected
[2]
38 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Understanding Defects
Start Development Process Ship
} Shipped Defects
Defects
Defects Detected And Corrected Defects
Injected
[2]
39
Overall Software Quality
Start Development Process Ship
Defects
Inject Fewer
[2]
40 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Software Quality Model
Understanding Defect Injection Rates
Software Detailed Design
Software Coding Software
High-Level Design Software
Requirements
Defect injection rates can be reduced
by
Performing these activities highly effectively
and introducing Causal Analysis
41
Understanding Defect Injection Rates
Software Detailed Design
Software Coding Software
High-Level Design Software
Requirements
Defect injection rates will increase
if
You do not perform these activities well
or you decide not to do the activity at all
42 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Software Quality Model
Understanding Defect Injection Rates
Software Detailed Design
Software Coding Software
High-Level Design Software
Requirements
Defect Injection Rates are directly related to the completeness and the effectiveness of each
of these activities
43
Understanding Defect Injection Rates
0 10 20 30 40 50 60 70 80 90 100
Sys Reqs
SW Reqs
HL Design
Det Design
Coding
Unit Test
Int Test
SW Sys Test
Sys Valid
Beta Test
Customer
Defects per 1000 lines of code
Defects Injected
Cumulative Defects
44 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
A Journey To Fewer Defects
Overall Software Quality
Start Development Process Ship
Detect Earlier
Detect More Effectively Defects
Inject Fewer
[2]
45
Increasing Effectiveness
Verification
Unit Test
Verification
Software
Detailed Design
Software Coding Software
High-Level Design Software
Requirements
Verification Verification
Integration Test
Software System
Test
System
Validation Beta Site
Testing Customer
46 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
A Journey To Fewer Defects
Overall Software Quality
Start Development Process Ship
} Defects Fewer
Detect Earlier
Detect More Effectively Defects
Inject Fewer
Zero?
[2]
47
Introduction
Regulated Software FDA Overview
Medical Device Definition Software – Special Attention Regulation Of Software
Basic Requirements Software Quality Model Software Safety Model Software Maintenance
Corrective Action and Preventive Action (CAPA) Reference Material
Conclusion
Medical Product Software Development and FDA Regulations
48 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Software Safety Model
Risk/Hazard Analysis & Use Error Analysis
Verification
Unit Test
Verification
Software
Detailed Design
Software Coding Software
High-Level Design Software
Requirements
Verification Verification
Integration Test
Software System
Test
System
Validation Beta Site
Testing Customer
Risk/Hazard Analysis Use Error Analysis
Harm To:
Patients Operators Bystanders
Service Personnel
Environment
49
Risk/Hazard Analysis & Use Error Analysis
Verification
Unit Test
Verification
Software
Detailed Design
Software Coding Software
High-Level Design Software
Requirements
Verification Verification
Integration Test
Software System
Test
System
Validation Beta Site
Testing Customer
Risk/Hazard Analysis Use Error Analysis
Induced By:
Basic Functionality Software Defects Use Errors
Environment
Interfaces
50 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Verification
Unit Test
Verification
Software
Detailed Design
Software Coding Software
High-Level Design Software
Requirements
Verification Verification
Integration Test
Software System
Test
System
Validation Beta Site
Testing Customer
Software Safety Model
Risk/Hazard Analysis & Use Error Analysis
51
Risk/Hazard Analysis & Use Error Analysis
Verification
Unit Test
Verification
Software
Detailed Design
Software Coding Software
High-Level Design Software
Requirements
Verification Verification
Integration Test
Software System
Test
System
Validation Beta Site
Testing Customer
Risk/Hazard Analysis
Use Error Analysis
52 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Software Safety Model
A Continuous Process Throughout the Life Cycle
Verification
Unit Test
Verification
Software
Detailed Design
Software Coding Software
High-Level Design Software
Requirements
Verification Verification
Integration Test
Software System
Test
System
Validation Beta Site
Testing Customer
Risk/Hazard Analysis
Use Error Analysis
53
A Continuous Process Throughout the Life Cycle
Verification
Unit Test
Verification
Software
Detailed Design
Software Coding Software
High-Level Design Software
Requirements
Verification Verification
Integration Test
Software System
Test
System
Validation Beta Site
Testing Customer
Risk/Hazard Analysis
Use Error Analysis
54 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Software Safety Model
A Continuous Process Throughout the Life Cycle
Verification
Unit Test
Verification
Software
Detailed Design
Software Coding Software
High-Level Design Software
Requirements
Verification Verification
Integration Test
Software System
Test
System
Validation Beta Site
Testing Customer
Risk/Hazard Analysis
Use Error Analysis
55
Use Error Analysis
User Error
Blames The User For Doing Something Wrong
Developer takes accountability for developing software that allowed the user to make an error
User Error – Use Error –
X
And…..the developer incorporates Use Error Analysis into the risk management process resulting in
the implementation of built-in safeguards to protect
against Use Error
56 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Software Safety Model
Use Error Analysis
Use Error (Human Factors) Considerations
z Skill Level Variation
z Environmental Variation
z Compromising Factors
z Physical and Sensory Characteristics
z Perception
z Cognition
z Expectancies
z Mental Models
z Home Use
57
Risk/Hazard Analysis & Use Error Analysis
Interfaces Environment
Use Errors Defects
Basic Functionality
Potential Harm To
Environment
Potential Harm To
Service Personnel
Potential Harm To
Bystanders
Potential Harm To
Operators
Potential Harm To
Patients
You are developing a function where the user will be asked to
manually enter a patient’s age
YES
You realize that if the age is entered incorrectly that an incorrect diagnosis
might be made
58 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Software Safety Model
Risk/Hazard Analysis & Use Error Analysis
Potential Hazard Potential
Event Severity Control
Mitigation
Post Control Severity
V&V Function
Feature Patient
Age Entry
Incorrect Diagnosis Incorrect Age
Entered
(Use Error)
Major Enter
Date of Birth (cross check)
Acceptable
Test Procedure
12345
59
Risk/Hazard Analysis & Use Error Analysis
60 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Introduction
Regulated Software FDA Overview
Medical Device Definition Software – Special Attention Regulation Of Software
Basic Requirements Software Quality Model Software Safety Model Software Maintenance
Corrective Action and Preventive Action (CAPA) Reference Material
Conclusion
Medical Product Software Development and FDA Regulations
61
Recall Statistics
FDA Analysis – 3140 Recalls (1992 – 1998) Software-related recalls – 242
Software recalls due to changes – 192 (79%)
“Of those software related recalls, 192 (or 79%) were caused by software defects that were introduced when
changes were made to the software after its initial production and distribution”
Software Related Recalls
Due To Changes (79%)
Initial (21%)
FDA Guidance (2002) General Principles of Software Validation
62 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Maintenance Challenges
Maintenance Challenges
Oversimplification of the task Customer and Patient expectations Increased requirements on system
Changes
Design additions and/or modifications State of the documentation
Knowledge level Personnel changes
Software components (COTS) Hardware components
Interfaces
Cybersecurity issues
63
Creating A Balance
Challenges
Oversimplification of the task Customer and Patient expectations Increased requirements on system
Changes
Design additions and/or modifications State of the documentation
Knowledge level Personnel changes
Software components (COTS) Hardware components
Interfaces
Cybersecurity issues
Processes
Requirements management Anomaly management
Technology transition management Risk management
Training Change control
Software development life cycle Technical reviews
Validation planning Testing
Configuration management
Documentation updates
64 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Introduction
Regulated Software FDA Overview
Medical Device Definition Software – Special Attention Regulation Of Software
Basic Requirements Software Quality Model Software Safety Model Software Maintenance
Corrective Action and Preventive Action (CAPA) Reference Material
Conclusion
Medical Product Software Development and FDA Regulations
65
Corrective Action – Preventive Action (CAPA)
Problem Encountered Investigate
Find Root Cause Correct The Problem
Same Product Similar Problems?
Investigate Find Root Cause Correct The Problem
Other Products Similar Problems?
Investigate Find Root Cause Correct The Problem
Process Change Prevent Similar
Problems From Occurring In
The Future
66 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Introduction
Regulated Software FDA Overview
Medical Device Definition Software – Special Attention Regulation Of Software
Basic Requirements Software Quality Model Software Safety Model Software Maintenance
Corrective Action and Preventive Action (CAPA) Reference Material
Conclusion
Medical Product Software Development and FDA Regulations
67 Quality System
Regulation
The Regulation
• The Quality System Regulation 21 CFR 820
General Principles of
Software Validation
Software Pre-Market Submission Guidance
Off-The-Shelf Software Guidance
FDA Software Specific References
• General Principles of Software Validation
• Software Pre-market Submission Guidance
• Off-The-Shelf Software Guidance
Medical Device Quality System Manual
Design Control Guidance
Do It By Design
Guide To Inspections Of Quality Systems
(QSIT)
Medical Device Use Safety Human Factors
Risk Mgmnt
FDA General References
• Medical Device Quality System Manual
• Design Control Guidance
• Do It By Design
• Medical Device Use Safety (Human Factors/Use Errors)
• Guide To Inspections Of Quality Systems (QSIT)
Industry References
• ANSI/AAMI SW68
• ISO 62304
ANSI/AAMI SW68:2001 Software Processes
ISO 62304
ISO 13485
ISO
14971
• ISO 13485
• ISO 14971
68 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
General Principles of
Software Validation
Software Pre-Market Submission Guidance
Off-The-Shelf Software Guidance
FDA Software Specific References
• General Principles of Software Validation
• Software Pre-market Submission Guidance
• Off-The-Shelf Software Guidance
Industry References
• ANSI/AAMI SW68
• ISO 62304
ANSI/AAMI SW68:2001 Software Processes
ISO 62304
69
FDA Software-Specific Guidance Documents
70 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
FDA Software-Specific Guidance Documents
71
Medical Device Software - Software life cycle processes
72 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
AAMI TIR32:2004
Medical device software risk management
73
FDA Website www.fda.gov
Click On
“Medical Devices”
74 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
FDA Website CDRH A-Z Index
Click On
“CDRH A-Z Index”
75
Click On
“S” For Software
76 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
FDA Website
Scroll Down To
“Software”
77
78 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
FDA Website
http://www.fda.gov/cdrh/humanfactors/
79
AAMI Website www.aami.org
80 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Quality System Regulation
Medical Device Quality System Manual
Design Control Guidance
Do It By Design
Guide To Inspections Of Quality Systems
(QSIT)
Medical Device Use Safety Human Factors
Risk Mgmnt
General Principles of
Software Validation
Software Pre-Market Submission Guidance
Off-The-Shelf Software Guidance
ANSI/AAMI SW68:2001 Software Processes
SW Risk/Hazard Analysis SW Human Factors (Use Errors) SW Change Control
SW Configuration Management SW Problem Tracking & Resolution SW Traceability
Non-Product Software Validation
Design Transfer Design History File Training
Software Quality Audits SW Architecture Verification
SW Detailed Design
SW Detailed Design Verification SW Coding
SW Code Verification Unit Test
Integration Test SW System Test Beta Testing SW Verification SW Validation
COTS Software Components Procedures
Plans
SW Life-Cycle Model SW Requirements Analysis SW Requirements Verification SW Architectural Design
Corrective & Preventive Action (CAPA)
81
Introduction
Regulated Software FDA Overview
Medical Device Definition Software – Special Attention Regulation Of Software
Basic Requirements Software Quality Model Software Safety Model Software Maintenance
Corrective Action and Preventive Action (CAPA) Reference Material
Conclusion
Medical Product Software Development and FDA Regulations
82 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Software Quality Model
Verification
Unit Test
Verification
Software
Detailed Design
Software Coding Software
High-Level Design Software
Requirements
Verification Verification
Integration Test
Software System
Test
System
Validation Beta Site
Testing Customer
Low Defect Injection Rates
Early and Highly Effective Defect Detection Steps
Risk/Hazard Analysis Use Error Analysis
CAPA
83
Patients
Operators Bystanders Service
Personnel Environment
It’s All About Making It Safe
Your Families! - Your Loved Ones! - Your Friends!
Each and Every One Of YOU!
84 Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
Carl R. Wyrwa
[email protected] MedicalDeviceSoftware.com
UC Irvine Extension Program
Medical Product Development Medical Device Engineering
BME X401
Software-Controlled Medical Devices Software Engineering & Compliance
http://unex.uci.edu/certificates/life_sciences/medical_products/details.asp
85
