Regulatory Services

Technical Documentation

• Design and manufacturing documentation
• V&V documentation
• Risk management documentation
• GSPR checklist
• IFU, Label, Declaration of Conformity
• Technical Documentation compilation

Post-market Technical Documentation

• PMS Plan and Report, PSUR
• PMCF/PMPF Plan and Report
• SSCP/SSP and lay person readability testing
• Planning of PMS and PMCF activities
• Evaluation of PMCF study needs

Clinical Evaluation (MDs)

• Clinical Evaluation Plan, including Clinical Development Plan
• Clinical Evaluation Report
• Literature Search Plan and Report

Performance Evaluation (IVDs)

• Performance Evaluation Plan and Report
• Scientific Validity, Analytical Performance, Clinical Performance Plans and Reports

Transition to MDR/IVDR

• Audits and gap assessment for MDD to MDR/IVDD to IVDR
• Implementation of gaps and transition of manufacturer documentation

Roadmap to CE-mark and regulatory strategy

• Basic product characterisation, key steps Gantt chart, preliminary estimation of timelines and budget
• MDR/IVDR product Approval Requirements
• Defining device characteristics (qualification, classification, intended purpose, WET/legacy device justification, Software as Medical Device, combination products)

Device portfolio prioritization

• For companies with a large portfolio of products under development/transitioning to MDR/IVDR
• Revision of preliminary clinical evidence, SOTA and TD status for selection of candidates closer to meeting requirements for CE-mark

Assessment of sufficient clinical evidence

• Strategies for legacy and well-established technologies
• Evaluation of need of PMCF/PMPF study
• Clinical evidence search and analysis

NB/CA/Economic operators

• Notified Body management: selection, support in responses to non-conformities and document corrections
• Communication and liaison with National Competent Authorities
• Registration of Economic Operators: from national authorities to EUDAMED