Medical DeviceQualified Supplier Directory

Expandable Software

900 Lafayette
4th Floor
Santa Clara, 
CA  95050  us
Tel: 408/261-7880
Fax: 408/247-2160

Expandable Software, Inc. provides a complete enterprise system that installs the structure and controls that help medical technology manufacturers successfully manage finances and production while meeting the stringent requirements of the FDA and other regulatory bodies.

The Expandable system is a full-featured, robust, modular, easily scalable and highly user-friendly business management suite that serves as the core quality system for companies regulated under ISO13485, FDA CFR 21 Part 820 and other international guidelines.

Built into Expandable's DNA is the commitment to providing a solid solution that meets medical manufacturing needs at each level of the business growth cycle. Expandable medical device and technology customers range from start-up companies progressing from seed funding through initial product FDA listing, IDE clinical trials and full 510K/PMA approvals, to multi-divisional manufacturers serving worldwide markets.

Expandable for Medical Technology
The Expandable system includes the critical functionality medical technology companies require to manage a complex manufacturing environment and maintain FDA compliance:

  • Product Design Controls
  • Lot and Indented Serial Number Tracking
  • Shelf Life Dating
  • Multiple Units of Measure
  • Multi-currency Accounting
  • PLM, CRM and QSM Interfaces for ERP
  • Electronic Record Keeping
  • Quality Management
  • Advanced Security
  • Discrepancy Reporting
  • Alerts and Messaging
  • Consignment Inventory
  • Audit Trails
  • Return Materials Authorization
  • Encrypted Password Protection
  • Validation Assistance
  • Warranty Tracking

In addition to providing the controls, traceability, quality and cGMP methods mandated by QS regulations, Expandable's fully integrated ERP suite delivers the full range of management reporting tools and financial checks and balances for meeting GAAP/SOX and international accounting standards.

ERP for Growth
Expandable's unique approach delivers a scalable business platform with the Expandable system providing the core transactional database, fundamental business logic and financial checks and balances necessary for auditable business operations. With incremental deployment of optional Expandable modules as growth requires, and tight ERP integration to leading third-party business partner solutions like CRM (see Expandable on AppExchange), PLM systems, Quality Management Systems (QMS) and other extensions, growing companies gain a highly efficient business platform that can be tailored to match business goals and operational strategies.

Expandable Customers
Expandable's base of medical technology customers covers every device class, classification panel and medical application area. Expandable customers encompass the full range of devices, are 100% available for reference, and cultivate industry expertise through the International Expandable Users Group Association (IEUGA) that sponsors both regional and international meetings.

About Expandable Software, Inc.
Since 1983 Expandable Software, Inc. has been providing reliable manufacturing solutions to companies producing advanced medical technology.

From pre-approval startups to divisions of the most recognized names in the life sciences industry, Expandable's ERP system is the business foundation of manufacturers producing a wide assortment of medical technology products.

Implementations of Expandable's ERP products are accomplished in just a few weeks, and the system is backed by the industry's most knowledgeable and responsive customer support professionals.

The Expandable system can be deployed on-site or in the software-as-a-service (SaaS) model.