2. S U M M A R Y
ALM solution provider (Application Lifecycle Management)
Focusing on the medical device industry
Over 60 top tier clients such as Biosense(J&J), Medtronics, Mazor Robotics and others
Full collaborative SaaS solution
Providing significant edge over potential competition

3. C L I E N T S

4. O V E R V I E W
Current medical device market issues...
High costs for FDA/CE approval for
medical devices (~$20m)
Rising FDA/CE restrictions increase
operational costs for startup companies
and increase risk of recall for
established ones
Product and application lifecycle
management becomes critical for both
control and audit purposes

5. T H E N E E D
Vertical ALM system to integrate
between R&D, quality control and
regulatory audit and requirements,
for medical devices and pharma
companies
R&D
QUALITY REGULATION
MedicalDevices&Pharma

6. T H E G A P
No specific solution serving
medical companies’ needs
Many disjointed service modules
for separate functions
No real integration between R&D
and quality processes with
regulatory requirements
Major players are either
generalists or too expensive

7. S O L U T I O N
Orcanos | ALM
We have adapted ALM
cycles and process
management to meet
specific medical device
R&D and regulation
requirements* for
maximum risk reduction
and cost savings
*FDA compliant
Risk Management

8. S O L U T I O N
Industry specific vertical
framework
Covering R&D and Quality
processes all the way till
regulatory submission
Streamlining and
automating over 80% of
the manual paperwork
management, audit
control and compliance
alerts
Quality Control

9. C O M P O N E N T S
Requirements Management
Test Management
Defect Tracking
Issue Tracking
Service Center
FMEA Risk Management (ISO 1497)
Document Control
CAPA
ECO
Complaints

10. V A L U E
Manual maintenance
Manual search for info
Manual documents
management
Manual Maintenance
Manual risk management
Singular solutions
TYPICAL IMPEDIMENTSVALUE CREATION VALUE DRIVERS
VALUE PROPOSITION
Decrease
Risk
Decrease
Cost
End-To-End Traceability
Embedded Risk
Management
Compliance based
Alerts
Automate
Document Control
Integrated
System
Process
Automation

11. O U R E D G E
Application specific lifecycle management
Virtually supporting the regulatory expert
Industry related automation of processes, traceability and verification
Linking risk management with design process
Automatic impact analysis - how a change can affect your project (regulation, costs...)
Multi-user collaboration

12. B O T T O M L I N E
Specialized ALM solution
Not “all things to all products”
Vertical audit & regulation focus
Enabling significantly higher reduction of risk & cost
SaaS model
Lower cost of ownership