Software QA, Documentation and Regulation

Internal Software Quality Assurance keeps projects in line with FDA, CE, and medical/pharma international standards

Gain Confidence

Whether partnering in developing software solutions or testing a completed product for the market, we’ll review your project, fix errors, and bring it up to the latest regulation standards.

Prepare everything for submission of your product to regulatory bodies, knowing it surpasses their standards. With paperwork in order and due diligence completed by a team you trust, you can get ready for the next stage of the product’s journey.

Test What Matters

With decades of Software Quality Assurance and regulation experience, we’ve been there before. Investing in ongoing research keeps us up to date on ever-changing regulation and shortens your time to market.

Your project becomes the focus of a dedicated team of engineers who take it upon themselves to create a viable solution. With continuous regulatory changes across multiple bodies, we keep up to date on all new policies, so your product remains in operation.

We focus on:

  • ISO-Based QA
  • Risk/safety management
  • Full SQA services
  • GAMP compliance
  • FDA/CE compliance
  • Software Validation & Verification
  • Validation of any process based on software systems
  • Software Development Lifecycle procedures
  • Software templates
  • Software Forms
  • Software development documentation
  • Software application testing
  • Full SQA Procedures including: Design reviews, unit testing, integration testing, verification testing, static analysis, code reviews, code control, and bug tracking