Hier finden Sie die Folien von Dagmar Glashoff-Dedeck zum Medical Workshop

1. Effektives Anforderungsmanagement mit Polarion
ALM für die Medizintechnik
Dagmar Glashoff-Dedek, Maxim Damm und Lukas Vogler
30. März 2016

2. Über Polarion
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3. ✓ 2004 Gründung mit disruptiver Vision
✓ 2005 Erste durchgängige, 100% web-basierte ALM-Lösung
✓ 10 Jahre Fokus auf Synergieeffekte:
✓ Vollständige Nachverfolgbarkeit, Echtzeit-Zusammenarbeit, intuitive
Benutzeroberfläche
✓ 10 Jahre Kundenzufriedenheit & Wachstum
Fortune-1000-
Implementierungen
250+
Anwender
2,5+M
Erweiterungen
200+
Registrierte
Community-Mitglieder
15Tsd
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4. Analysts Assessment
“We have rated Polarion Software as a ”Visionary”,…
with a strong single-platform toolset
that covers the entire life cycle
and promotes traceability and compliance
with International Organization for Standardization (ISO), FDA...”
- Thomas E. Murphy, Jim Duggan, Nathan Wilson

5. Kunden
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6. Customer Success Stories
“Polarion provides us the
foundation for submitting
for FDA 510K Clearance”
“Polarion provides
everything we need!”
Lifewatch Monitors
Compliance and
Unifies Teams
Sirona Dental
Systems Polishes
Process
“Sirona Dental Systems uses
Polarion Solutions not solely to
achieve compliance with
medical device regulations like
FDA or IEC 62304 but
moreover to make all data in
the development process
lifecylce more transparent for
all parties involved, like
developers, project managers
and quality managers. That’s
reached by using Polarion’s
flexibility and adaptable
reporting capabilities. The
result is a more efficient and
transparent document
handling thanks to Polarion
Solutions.”
Michael Dalpiaz, Sirona Dental
Systems

7. •Polarion’s Differentiators

8. Unified Solution Solves and Evolves
Requirements
Management
Test & Quality
Management
Issue & Defect
Management
Variant
Management
Change &
Configuration
Build & Release
Management
Resource
Management
Audits, Metrics,
& Reports
ALM
QA
ALM
RM

9. Certified Tool w/ Standards Templates
• Only ALM Tool Certified for IEC 61508/ISO 26262
• Templates for CMMI, FAA, FDA, IEC, ISO, SPICE etc.
"We’re just thrilled about Polarion’s tool qualification for ISO
26262. This saves us a lot of time and money in our own
qualification process.”
- Maria Eugenia Zuniga, Quantum Technologies
- Maria Eugenia Zuniga, Quantum Technologies
Maria Eugenia Zuniga, Quantum Technologies

10. Agility through direct, real-time collaboration
The Power of Polarion
Productivity through streamlined workflows
Predictability through better estimation and reporting
Quality through integrated processes
Compliance through traceability and accountability
Innovation through unlocked team synergy