Quality

Gsap establishes a culture for quality and improves the quality system management (QMS). We develop together with the client a comprehensive quality system to suit the organization and the product, for clinical care and commercial applications. Our quality experts in Gsap, can help you establish these matrices, properly collect the data, analyze the results and set actions for improvement. These effective implementation principles are followed: (i) Manage the Metrics, ((ii) Interpret in context, and (iii) Apply internally.

Risk management

According to applicable standards such as ISO 14971 ,including dFMEA & pFMEA


Design & development controls

Including design reviews and planning of product realization


Product Verification and Validation (V&V)

Support writing and review of protocols and reports


Purchasing controls and acceptance

Sampling inspection according to international standards and applicable statistical guidelines


Transfer to production

Quality planning and execution of transfer to production and Process Capability analysis


Process Verification and Validation

Including IQ/OQ/PQ/TMV


Quality improvement

Non-conforming product (NC), Complaint handling, Corrective and Preventive Action (CAPA)


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