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Design, Development, and Implementation of Quality Systems

Appropriate design and implementation of quality systems in the development and distribution of Health and Life Science products is essential to guarantee the quality, safety, and efficacy of the products.

At ClarkeModet we help our customers to comply with the required quality standards and regulations, according to the type of product and activity (GxP, ISO 13485, ISO 15189, ISO 22716, ISO 16128…), as well as to continuously improve their processes and products.

The comprehensive support we provide in this area includes: (i) the initial assessment of the client’s situation, to understand its operations, products, applicable regulations, and specific challenges faced by our clients; (ii) the design of a customized quality system based on internationally recognized quality standards, which is tailored to the client’s needs and objectives; (iii) the creation of the necessary documentation, such as quality manuals, SOPs, registration forms and any other documents required according to the Quality System that may be applicable; (iv) training of the organization’s personnel to ensure that they are aware of and updated on the Quality System, which is crucial for effective implementation; (v) support to our clients in implementing the Quality System, which may involve changes in operational processes, the incorporation of new practices and the integration of Quality Systems into the day-to-day operations of the organization.


Sector Químico-Farmacéutico


Sector Biotecnológico


Sector automoción

Medical Devices

sector alimentación


sector textil


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Experts in Design, Development, and Implementation of Quality Systems

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Ana Cristina García
Country Managing Director Paraguay

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