Services

Services 2018-01-30T13:50:41-08:00
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
  • Training and mentoring 
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 classes and materials
  • 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

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.

 

 

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.

sharks

How can we help?