What We Do

We provide expert advice on regulations and standards that apply to software in medical devices and software used for clinical trials.

When time and money matter so do knowledge and experience.

Done correctly, you'll run more efficiently and get to market faster:

Complexity is increasing for both organizations and individuals. At the organizational level, complexity multiplies with layers upon layers of government regulations, in multiple countries, combined with requirements from customers with their own unique specifications. Increasing regulatory responsibility is a top concern for being able to compete in the future. Complicated regulations can create complex processes and policies, which may lead to massive inefficiencies.

We strive to keep it simple and not fog up your business practices unnecessarily.

Regulatory compliance can be used to drive improved, more cost-effective software practices. This is because regulations and standards embody best practices which are not always known by software professionals.

Where We Can Help

  • 510(k) Documentation.
  • CE Mark Documentation.
  • SOUP/Third-party/open source software.
  • Commercial Off-the-Shelf Software (COTS)
  • Software Testing, Validation and Verification.
  • Software Requirements Decomposition.
  • Embedded Software and Firmware.
  • Software-Only Medical Devices.
  • Software Requirements Specifications and Architecture.
  • Preparation for BiMo and ISO audits.
  • Gap Analyses and 21 CFR Part 11 Compliance Audits.
  • Regulatory Software Strategy.
  • Software Life Cycle and Development Environment.
  • Coding Standards.
  • SOPs for Software Development that meet requirements.
  • ISO 14971 Software Risk Management.and ISO 13485 Quality Systems
  • QSR Compliance.
  • Blood Establishment Computer Software.
  • Good Clinical Data Management Practices.