Medical Devices

Medical device companies have operationally intense manufacturing environments and a mix of non-technical and highly technical employees. They are a highly regulated industry with need for good process control, including FDA Title 21 CFR 11 and Good Mfg Practice (GMP).

Characteristic IT Environments

• Well defined IT processes and procedures for audit (IT documentation)
• Regulatory compliance
• Support of ERP, CRM, PDM and call center systems

Key ERP requirements for the medical device industry

• Data validation, security and process integrity
• 21 CFR 11 audit trails
• Adverse Event reporting
• Full product genealogy for traceability and recalls
• Cradle to grave serial/lot traceability
• Audit trail tracking in areas of ERP that are FDA significant (quality records, engineering changes, process instructions, etc.

Representative Medical Device Customers

• A manufacturer of premium performance compact ultrasound solutions which combines its proprietary technology with an innovative physical design.
• A manufacturer of medical imaging systems for minimally invasive surgery (MIS) viewing applications. The company continues the tradition of innovation with technological and engineering advances serving the rapidly developing surgical, interventional, integration, and infection control markets.
• A manufacturer of next-generation embedded hearing solutions.