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Our Services

1

Clinical Safety Documentation

  • Introductory call and high-level company and product overview

  • Produce company Clinical Risk Management System and associated processes

  • Produce Clinical Risk Management Plan (per product)

  • Produce initial Hazard Log (includes preparation, overview, SWIFT session, hazard workshop and documentation of hazards identified)

  • Continuation Hazard workshops

  • Produce final approved Hazard Log (includes risk assessments pre and post mitigation, review of mitigation evidence (design, test, training and business process) and DCB0160 handover of transferred risk)

  • Produce Clinical Safety Case Report and provide final safety sign off

2

Clinical Safety Reviews

  • Review of existing Clinical Risk Management System and associated processes

  • Review of existing Clinical Risk Management Plan (per product)

  • Review of existing Hazard Log (per product) and associated mitigations

  • Review of existing Clinical Safety Case Report and File evidence

  • Provide final safety sign off once satisfied with safety deliverables

3

Additional Services

Introduction on Clinical Incident Management Process

Clinical Safety Officer Training

Clinical Safety Incident Management – 1 day per month (includes review of issues, incidents, near misses, complaints logged in past month)

Medical Device Qualification & Classification Review

Annual CSCR Review (with or without additional functionality)

No plans availableOnce there are plans available for purchase, you’ll see them here.
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