Developing for Market Clearance

Strategic planning for proof of concept (POC), performance, safety, & functionality testing for the defined Intended Clinical Indications for Use. Identifying key user, regulatory requirements, applicable standards and verification testing plans for design, components, materials, manufacturing / assembly processes, packaging & labelling & sterilisation. Supporting manufacturers & distributors address and meet EU regulations (EU) 2017/745 (MDR), 746 (IVDR), UK MDR, standards and/or common specifications for CE Mark, UKCA Mark & UKNI Mark & other national requirements

Expert resources, advices, planning and development to implement best fit practices and controls for:

  • POC including technology application re: clinical need, indications for use & application

  • Specification development, definition, including Human Factors, User and Interface Requirements

  • Identification of national and international standards for test.

  • Materials selection, biocompatibility & testing protocols

  • Specific country applications / clearances e.g. US, EU, UK & other countries.

  • Software Life-Cycle to meet IEC62304

  • Clinical Evaluation

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    Design / Develop D&D planning, user requirements, verification, validation & change. Risk Management Planning, hazard identification, risk control, benefit-risk analysis. Audit & Monitor Obtaining data to verify compliance: Improve product(s), plant(s), processes, people & controls. Services Technical Documentation Tech Doc collation to evidence safety & performance & meet national regulations. Change Control Controls & risk management of changes to device(s), processes, systems & Tech Documentation. Clinical Evaluation Clinical Evaluation planning, data review, reporting & updating. Services Data Analysis Practical, proven, efficient KPI's to identify, collate, analyse, act & improve products, processes & people. Doc & Data Control Efficient, reliable, traceable Doc & Data controls. Launch & Distribute Importer / Distributor QMS, agreements, traceability, controls and diligence. Services Management Systems Developing & maintaining effective, compliant QMS; improving product, resources, processes & organisation. NCR & CAPA Identifying, recording, analyzing, preventing & correcting product, process & system issues. Ops Management Effective compliant, efficient controls, (incl. outsourced processes). Services Performance Improvement Implementing improvement in your device life-cycle & compliance. Regs & Standards Identifying & meeting relevant regulations, common specifications & standards. Reg Strategy & Plan Regulatory strategies / plans for device development & clearance to market; FDA, CE, UKCA, UKNI. Services Reg Submission Preparing & collating data to reduce time for complaint submissions to gain clearance for product launch. Verification & Validation Planning, verifying, validating designs, processes, environ controls, equipment, products, plant & test methods. Vigilance & PMS Documenting & implementing PMS / PMCF plans, vigilance system & incident reporting. Services GPB - Design Control GPB - Risk Mangement GPB - Audit Monitoring GPB - Technical Documentation Change Control Clinical Evaluation Data Analysis Doc & Data Control Launch & Distribution Performance Improvement Regulation Standards Regulatory Standards Management Systems NCR & CAPA Operations Control Regulatory Submissions Verification & Validation Vigilance & Post Market