Proven Solutions for
Medical Technology Manufacturing.
In the medical technology
arena you're faced with some of the most challenging
demands in the business world. Compliance
with the FDA and other regulatory bodies,
stringent quality assurance requirements,
and the urgency of accelerated timetables
due to increased global competition are a
few of the obstacles you must hurdle just
to throw your hat into the ring.
Expandable clears your path to success
with a proven solution that meets both your
system and regulatory requirements with
a straightforward and cost-effective approach.
Targeted
Functionality
Expandable's
integrated ERP system includes specific capabilities
to manage your complex manufacturing environment
and maintain FDA compliance. You'll keep costs
low and margins high while adhering to the
strict quality and regulatory requirements
of your industry.
Lot Tracking
Serial Number Tracking
Shelf Life Dating
Multiple Units
of Measure
Multi-currency
Accounting
Product Data Management
Integrated Quality
Assurance
Product Cost Management
Shop Floor Control
Business Intelligence
Versatile Inquiries
and Reporting
Return Material
Authorization (RMA)
Streamlined Regulatory
Compliance
Expandable's comprehensive
software validation program includes full
compliance support and delivers the protocols
and documentation required to manufacture
FDA-regulated products. Pre-written installation
qualification (IQ) and operational qualification
(OQ) scripts expedite the validation process.
Software Validation
Risk Analysis
System Validation
Master Plan
Functional Requirements
Specification Document
Functional System
Design Specification Document
Validation Protocols
(IQ/OQ)
Performance Qualification
(PQ)
Protocol Approval
Incident Review
Revalidation
Expandable's
medical technology solution combines regulatory
experience with rock-solid manufacturing capabilities
to provide you with tools to increase your
competitive advantage, sustain high quality
standards, collaborate effectively with your
supply chain and maximize customer satisfaction.
Key
Facts
Expandable
medical technology customers range from pre-approval
startups to divisions of Fortune 500 companies.
Expandable
has implemented its ERP solution at divisions
of industry-leading medical technology companies
including Medtronic and Baxter.
Expandable's
integration with PLM software from Agile, Omnify and Arena helps medtech manufacturers
manage revisions, minimize time-to-market
and ease compliance issues.
Read
how FDA-regulated companies like Thermage®
and Tom's
of Maine are using Expandable to grow
their businesses profitably.
Integrated Solutions
