Design Control

Establishing effective, efficient design & development processes and controls from planning to design validation and transfer. Applying QFD and QbD principles to meet user/patient needs and demonstrating compliance with medical device Quality Systems, ISO / National Standards and country regulations.

Improving all aspects of Design Control including:

Intended Use / Purpose
Human Factors and Usability to meet ISO/IEC 62366 and ANSI/AAMI HE75
Design Input Requirements / Output
Materials selection / biocompatibility
Design Verification, Testing & Review

Design Validation to evidence safety and performance
Design History File (DHF) compilation
Software Life-Cycle to meet IEC62304
Design Change Control and Approval
Design Transfer to Manufacture

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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.

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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