INTRODUCING CLARIFY CLINICAL
Clinical . Safety . Governance . Regulation
Welcome to Clarify Clinical. Your products and their safety is important to us. We’re eager to support your needs and provide the necessary guidance to achieve a successful product launch. A professional consultancy service that’s ready to deliver tailored Clinical Safety & Medical Device Software advice.
Clinical Safety Services
Bespoke service tailored to the size and nature of your organisation.
Clinical safety documentation can be provided from scratch or a review and audit of your existing documentation and processes may be all you require
Clinical Safety Documentation
Introductory call and high-level company and product overview
Produce organisation wide Clinical Risk Management System and associated processes
Produce Clinical Risk Management Plan (per product)
Produce initial Hazard Log
Continuation Hazard Workshops
Produce final approved Hazard Log
Produce Clinical Safety Case Report and provide final safety sign off
Clinical Safety Review
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
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Additional Services
Introduction on Clinical Incident Management Process
Clinical Safety Officer Training
Clinical Safety Incident Management
(includes review of issues, incidents, near misses, complaints logged in past month)
Medical Device Qualification & Classification Review
Annual CSCR Review (with or without new additional functionality)
