Development support

Examples of Grey RA development support activities in different product life cycle phases.

Pre-market: Feasibility phase

  • Defining a regulatory strategy
  • Applicable standards selection
  • Risk management planning and characteristics
  • Quality system implementation
  • Quality Management Systems audits and gap analysis

Pre-market: Development phase

  • Review of contracts and agreements
  • Applicable standards deployment
  • Risk management moderation
  • Smart Document Control solutions
  • Quality Management Systems audits and gap analysis
  • Setting Medical device Software processes

Pre-market: verification & validation phases

  • Applicable standard verification
  • Risk Management reporting
  • Ensure compliance with Essential Requirements and Essential Principles
  • Compilation of technical files
  • Management of submissions
  • Management of clinical evaluations

Post market

  • Support with medical device vigilance
  • Internal audits
  • Support with external audits and inspections
  • Management of re-submissions
  • Applicable standard monitoring and impact analysis
  • Management of post market surveillance and post market clinical follow-up