Quality Management Services
Maximize customer satisfaction and meet regulations with iDE8's comprehensive quality management solution. Our process covers all four essential components - Planning, Assurance, Control, and Improvement - from system creation to day-to-day management, ensuring a seamless and effective approach in the medical device industry.
Support
We work with you across all components from system creation to day-day administration.
Management Reviews
From planning to facilitation and action remediation, we work with your team as a Quality management reps.
Supplier Management
Working with your internal team and supply chain to support incoming goods and product quality.
Process Quality
Process quality is important for every business.
We help you measure and improve processes so that you release the best products.
Risk Management
Working with you on the assessment, control, communication, and review of quality risks.
Product Realisation
Working with you across the entire product life cycle from conception to completion.
Project Management
Helping you successfully manage quality projects for medical device products with our custom-tailored project management services.
Cost of Quality
Working across all 4 pillars to appraise, identify and reduce costs.
Training Management
Helping you track, train and ensure compliance with all required policies and procedures.
Non-conformity /
CAPA Management
Reducing the frequency and impact of nonconformances in terms of cost and resources and improve product/service quality and QMS effectiveness.
Statistical Analysis
Statistics support for process control, and product performance to monitor the quality of your products.
Complaints Management
Handling complaints that is systematic and orderly. To resolve issues while creating a positive impact.
Continuous improvement
Supporting your quality department in incremental and breakthrough improvements of products, services or processes.
Quality system Design
Bespoke quality system Implementation aligned to organisational goals and complaint to ISO 13485 and 21 CFR PART 820
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