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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.


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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Let Us Help You 

Get a complete solution for your medical device needs with iDE8.
As medical device consultants and contractors, we're your one-stop-shop for quality assurance and management in the ever-evolving medical device industry.

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