crew on deck

Deliverables

 

When it’s all hands on deck, we help you deliver

  • Risk analysis
  • V&V testing
  • Software validation
  • Requirements management
  • DHF documentation
  • Design Reviews
Steering

Procedures

 

We help you chart a course for better product development

  • Revise or rewrite SOP’s for design controls, risk management, software development, etc. 
  • Training and mentoring
  • Implement requirements management tool
  • Enhance collaboration and knowledge management
Knot

Expertise

 

Expert knowledge of options and their different uses and drawbacks for a variety of medical technologies and organizations. Experience with a broad range of clients, from startups to global corporations.

Tools

 

We know how to integrate modern software tools with your quality system for efficient and rigorous compliance.

collaboration

Collaboration

 

We work closely with your product development team, improving their individual skills while ensuring a smooth course through project deadlines.

sharks

Today’s challenges

Because of our R&D backgrounds, we understand the challenges teams face in developing innovative new products in a highly regulated industry:

  • Increasing regulatory requirements
  • Increasing software complexity
  • Cost pressures decreasing margins

Our aim is to go beyond compliance, enabling clients to become more efficient and flexible, able to support rapid development of innovative new products and manage multiple design changes throughout the life of that product.



How can we help