QbD: Design & Development Control

Effective, compliant design & development controls using Quality by Design (QbD) principles that:

  • encompass the complete device life cycle;
  • demonstrate medical device safety, performance & usability;
  • embrace international  / national technical standards and regulations.

With you we address state of the art & implement best design & development practices:

  • Intended Use and Purpose

  • User requirements, clinical need, Human Factors and Usability Specifications to meet ISO/IEC 62366 and ANSI/AAMI HE75

  • Design, Development & Risk Management plans

  • Materials selection and Testing e.g. mechanical, electrical & biocompatibility

  • Design verification planning, safety & performance testing

  • Design Verification & Validation to ensure manufacture / process definition and Clinical Evaluation

  • Design History File (DHF) collation

  • Built in or Stand Alone Software design & Life-Cycle to meet IEC 62304

  • Design Change Control & re-validation

  • Design Transfer to enable manufacture / assembly with defined product and process specifications

  • Standard Operating Procedures
  • QMS Standards
  • Regulatory Requirements
  • Intended Use and Clinical Claims
  • Design & Development Planning
  • DFMEA
  • Usability Specification
  • Risk Management Planning
  • Functionality
  • Software Lifecycle
  • Materials Selection
  • Biocompatibility
  • Labelling and UDI
  • Packaging
  • Safety Testing
  • Stability, Sterility and Shelf Life
  • Bench Studies
  • Design Review and Verification
  • Bill of Materials (BOM)
  • Performance and Safety Studies
  • Design / Software Validation
  • Design Release
  • Technical Documentation
  • Design History File (DHF)
  • Design Transfer / Design Change
  • UDI

More Information?

    Please complete the following contact form or contact us 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