Quality Services

Gsap establishes or improves the quality system for the client so it will include all aspects required in product development and manufacturing, by examination during the R&D process, technology transfer, labeling, packaging and distribution.

We identify the authorities’ requirements according to the field and product of interest and elevate the performance of our clients’ quality management system through effective implementation of ISO 9001, ISO 13485, FDA QSR, GMP, ISO 14971 and EU MDR and CMDCAS. Nevertheless, we develop with the client the proper quality system suitable for the stage in the product life cycle and guarantee a method that is suitable for clinical care and commercial applications.

As part of DTV (Design to Value) concept, we assist our customers to identify product parameters that contribute to the value of the product and eliminate the ones that only bring cost and add no value by establishing CTQs.

CTQ are the key measurable characteristics of a product or process whose performance standards or specification limits must be met in order to satisfy the customer needs. CTQs establish the critical requirements of the product specification.

This brings the company to add to the product features that promote sales and eliminating unnecessary features that only serve to drive costs.

At its heart, engineering is about using science to find creative, practical solutions. It’s a noble profession.
Queen Elizabeth II