Launch & Distribution

With you we ensure compliance all national regulations: e.g. MDR EU regulation (EU) 2017/745, IVDR regulation (EU) 2017/746 for CE Mark, UK Regulations for CA Mark to enable your device(s) placement in your chosen market.

With you we establish plans to implement / enhance efficiencies and demonstrate compliance in:

  • Meeting specific country regulatory requirements e.g. language / labelling

  • Contract Fulfilment Services (Warehousing / Order Processing / Distribution / Returns)

  • Distributor Identification

  • Fulfilment and/or Distributor Registration

  • Traceability

  • Vigilance & regulatory reporting arrangements

  • Device Installation / Servicing

  • Device returns

  • Fulfilment and/or Distributor Agreements

  • Standard Operating Procedures
  • Standards and Regulations
  • Distributor Agreements
  • Launch Planning
  • Distributor Training
  • Traceability
  • PMS Planning
  • Regulatory Clearance
  • Fulfilment Agreements
  • Distribution Controls
  • Distributor Registration
  • Audit and Monitoring

Would you like to know more?

    We commit to assist you with your enquiries. Please complete the contact form or use on one of the following:

    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