Quality Management System Development

The Quality Management Challenge

Whether your organization is a new start-up or a large and established equipment manufacturer, you may be confronted with a Quality management challenge. Those challenges can seem trivial on the surface but can be costly and time consuming during implementation. Most often, our customers who have a Quality Management gap just need a compliant solution that they can depend upon.

Realtime’s ISO Certification scope covers Design, Prototyping, and Testing Services in: Software Engineering, Embedded Microprocessor Systems, Safety and Risk Analysis, and Verification and Validation; Project Management; System Architecture and Development.

Realtime offers a broad range of documentation and process solutions, as well as expert services that can help address your organizational or product Quality needs:

  • Shepherding products through product safety & compliance testing (e.g., IEC 60601)
  • ISO 14971, IEC 62304, IEC 62366 Compliance Checklists
  • Materials Prep / Coordination with Test Lab
  • On-time Issue Resolution
  • Quality System Development / Integration / Training
  • Risk Analysis (ISO 14971) Facilitation
  • Site Systems Validation Planning
  • Validation of SOUP compliant with IEC 62304
  • Gap Analysis / Remediation of existing products to enable staying current with changing standards and regulatory requirements
  • Supplier Qualification / Audit
  • Internal Audits