Design / Develop
Does your design & development plans, processes, controls and records meet new regulatory requirements?
Monitoring safety & performance? Recording the clinical benefit-risk ratio of your devices as your PMS/ RM PLan?
Audit & Monitor
Audits realising efficiencies & improvements to your product(s), plant(s), processes, people and controls?
Does your Technical Documentation meet EU MDR & US DMR Regulations & evidence safety & Performance?
Can you track risk assessment & control of changes to your device(s) Processes, Systems & Technical Documentation?
Are your device(s) safe, perform & used as intended as
defined in your Clinical Evaluation Plan, Literature Review & Report?
Have you defined & implemented practical, proven, efficient processes to identify, collate, analyse & act on data?
Doc & Data Control
Satisfied with the efficiency and reliability of your Doc & Data controls essential for your QMS & Technical Documentation?
Launch & Distribute
Your distribution contracts / agreements define, traceability controls and diligence to report device issues on time?
Still receiving QMS non-conformaces? Ensure QMS focus on improving product, people, process & organisation?
NCR & CAPA
You identify, record & correct product, process, people, system issues & ensure the integrity of your devices?
You have effective operational controls, (incl. outsourced processes), demonstrating compliance and efficiency?
Implementing opportunities for improvement in your device life-cycle to improve compliance & enhance efficiencies?
Identified relevant regulations, Common Specifications & standards for your device(s) to ensure clearance to market?
Regulatory plans / strategies for device design & development, manufacture, transition to MDR & clearance to CE Mark?
Data prepared & collated for submission on time to meet MDR? Engaged with authorities e.g. Notified Body for review?
Verification & Validation
Are all your designs, processes, equipment, products, plant & test methods validated & subject to re-validation?
Vigilance & Post Market Surveillance
PMS / PMCF plans documented & implemented? Can your vigilance system & incident reporting meet regulations?