Our Services: The Medical Safety Design Process

Medical products that are safe and intuitive to use are the result of Medical Safety Design. We assist you in this process with our long experience and knowledge of all applicable standards.

In what development phase is your medical product? Whether you analyze, realize, implement, validate, evaluate or document - Medical Safety Design supports you in every product development stage.

Your way to safe and user-friendly medical products

• Phase 1-3: User Centered Design
  analyze
  context of use and risks of use
  design
  user interface and safety mechanisms
  implement
  prototyping and verification of functions
  validate
  usability tests and evaluation of identified risks of use
• Phase 4
  integrate
  new requirements based on clinical evaluation
• Phase 5
  document
  usability file, risk management file, design evaluation report

Whether it is about the Medical Safety Design Process or the conduction of individual methods: We offer the suitable solution independet of what phase your product is in.

The use of flexible modules of methods allows to combine the requirements of your product with Medical Safety Design. What modules are compulsory to comply with the standards? What distinguishes you from your competitors? We consult you on the selection and composition of the individual modules to find your individual solution.