The Medical industry is highly regulated with standards to manage risk and ensure quality and safety of equipment and thereby provide the highest level of patient safety. Medical Device development teams are faced with increased software complexity today when developing high quality devices. AgileMed, the conference dedicated to Agility in Medical Device Development, was a great platform to introduce codeBeamer Medical ALM. codeBeamer Medical ALM is a customized template for IEC 62304 compliance which is required for medical device development.

1. PAGE 1
agileMed 2014
codeBeamer Medical ALM for Medical Device
Development
PRESENTER: Rico Unger
2014
FEB
19
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2. 2005-2013 Statistics
170
180
160
170
143
140
120
Software Recall
100
Number of software recall
increased by 100% from 2010
to 2011
86
80
69
65
2006
80
72
2007
60
40
34
20
Number of
increasing
1st
class recall
0
2005
2008
2009
2010
2011
2012
2013
6
1st
In 2014 3 new class recall
already published
5
5
5
4
3
3
3
Average 80% are 2nd class
recalls
2
1
1
1
1
0
0
0
2005 2006 2007 2008 2009 2010 2011 2012 2013
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PAGE 2
FDA Recall

3. PAGE 3
Key Issues
Medical Device Producers face challenges
Reducing recall due to “embedded” software products’ failures
Mitigate risk properly
Achieve compliance with standards IEC/ISO/FDA
Balance effort/cost of quality assurance
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4. IEC 62304 compliance support
SOLUTION
codeBeamer is a complex ALM solution
supporting IEC 62304 standard based development
with Agile and Waterfall (V-model) methods
DemandRequiremenst
Management
SCCM
Test and QA
IT OperationDevops
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PAGE 4
Application Lifecycle Management

5. PAGE 5
Overview
Medical Wiki
Requirements
Trackers
Risk Management
Release
Management
Document
Management
Test and QA
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6. Web-based
Available via
Browsers,
(supported
databases are:
MySQL, Oracle)
PAGE 6
General Features
Customizable
Trackers, workflows,
permission,
dashboards
User-friendly GUI
Well-structured GUI,
intuitive, easy to use
RESTful API
Integration to third
party applications
- IEC 62304 compliance list
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7. PAGE 7
Medical WIKI
Medical Domain Knowledge Base
Covers all chapters of
IEC 62304
Direct links to codeBeamer trackers, reports,
workflow to provide evidence
Main elements:
• Software Development Plan
• Traceability matrix
• Risk Management
• Reports and Dashboards
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8. 1 IEC 62304 chapters and links to
codeBeamer support
2
Traceability matrix
3
QA Dashboards
4
Reports
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PAGE 8
Medical wiki

9. PAGE 9
Medical Trackers
Configuration Items
A
Requirements
Trackers
B
Releases, Test Cases,
Test Runs
Risk Tracker
C
Change Request Tracker
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10. 1 System, Software, Architecture
2
SOUP
3
Requirement Approval Workflow
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PAGE 10
Medical Trackers

11. Test Case 1
Requirement
Test Case 2
Test Case....n
Test Case definition based
on Requirements
TEST SETS
PAGE 11
Test Management and QA
Test Run 1
Test Run 2
Test Run..n
Add test Cases to
Test runs
Verify all
Requirements
Release 1.1....n
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12. PAGE 12
Risk Management Workflow
Mitigation action
documented
New
Submit
Verified
Reduction planned
Transition set
Mitigated
Risk Tracker History
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13. PAGE 13
Risk Assessment
Assess Inherent
Risk
Severity and
Likehood = IH Risk
Define
mitigation
action
Residual riskmitigated
Severity and
Likehood after
mitigation = RR
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14. Release Planning
Kanban Board
Release Verification
 Add requirements to release
from backlog
 Task status with WIP limits
 All RMs are released and
tested
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PAGE 14
Release Management

15. PAGE 15
Document Management
Central Document Repsitory, Versioning,
Permissions
Process Templates
QMS documentation
Risk Management File
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16. PAGE 16
Benefits
What you can achieve by implementing medical ALM?
+ Easier
standardization and
audits
- IEC 62304 - cost
reduction, increase
efficiency of audits
+ Significant time
savings
+ Full traceability
+ Agile-Waterfall
- Implementation
effort can be reduced
by 5-6 days
- Reduce cycle times,
test case coverage,
status management
- Both development
methods are
supported
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17. PAGE 17
Intland Software
Your German Partner
Intland Software is an Application Lifecycle Management (ALM) solution provider. At Intland we
are building software for great companies to make their systems better.
Established
1993
25.000 +
90.000+
codeBeamer users
worldwide
OSS-Javaforge users
North-America
Silicon Valley
Germany
HQ, Stuttgart
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18. PAGE 18
Customers
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19. PAGE 19
Contact
info@intland.com
Headquarters
Stuttgart - Germany
Gropiusplatz 10
Download medical ALM with
codeBeamer 7.2.1 from:
http://intland.com/download-center/
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