Certification

ISO 13485 standard: Inspection and support

CEI HALFAOUI audits, advises, and assists its clients in the implementation of ISO 13485; 2016 standard, stating the requirements of the Quality Management System (QMS) for Medical Devices.

Besides being needed in the approval documentation of medical devices deposited with the approval authority (the Ministry of Pharmaceutical Industry for the Algerian context), it’s required in the design, production, and throughout the life cycle of the medical device.

This standard guarantees the improvement of the processes effectiveness, helps deliver safe products, and reinforces clients’ trust according to ISO 13485 requirements.

How can you benefit from our “ISO 13485 guidance and support” service?  

With the guidance of our ISO 13485 2016 coaching experts, your firm will be able to :

• Produce safe and effective medical devices with enhanced quality operation system practices;
• Ensure compliance;
• Identify safety and performance risks of medical devices in agreement with ISO 14971 2019;
• Get prepared for CE marking of medical devices;
• Differentiate your products from the competition;  
• Enhance process effectiveness.

Who’s concerned by ISO 13485?  

The concerned companies by the ISO 13485 standard are:

• Medical devices maintenance companies;
• Manufacturers of medical devices;
• Medical devices repair companies;
• Suppliers of raw materials and services used in the design of medical devices;
• Medical devices distribution companies.

Why choose CEI HALFAOUI?  

CEI HALFAOUI, an ISO 9001 certified and independent industrial consulting firm, offers you its exclusive ISO 13485 training, inspection, and consulting.

Our experts will assist you from the” Gap Analysis” inspection and the elaboration of the action plan, to the implementation of procedures and appropriate actions through a discussed and an approved planning.

To provide quality services, you will benefit from an analysis adapted to your situation and regular follow-up/monitoring.Our services are based in Algeria. However, we operate on a regional scale (Africa and Mediterranean). Do not hesitate to contact us !