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