orcanos medical
TRANSCRIPT
S U M M A R YALM 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 othersFull collaborative SaaS solutionProviding significant edge over potential competition
C L I E N T S
O V E R V I E WCurrent 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
T H E N E E DVertical ALM system to integrate between R&D, quality control and regulatory audit and requirements, for medical devices and pharma companies
R&D
QUALITY REGULATION
Med
ical
Dev
ices
& P
harm
a
T H E G A PNo 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
S O L U T I O NOrcanos | 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
S O L U T I O NIndustry 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
Customer
Quality ControlAudit
ALM
C O M P O N E N T SRequirements ManagementTest ManagementDefect TrackingIssue TrackingService CenterFMEA Risk Management (ISO 1497)Document ControlCAPAECOComplaints
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
DecreaseRisk
Decrease Cost
End-To-End Traceability
Embedded RiskManagement
Compliance based Alerts
Automate Document Control
Integrated SystemProcess
Automation
O U R E D G EApplication 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
B O T T O M L I N ESpecialized 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