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