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QA INSIGHT Ltd. is an independent and experienced contract QA consultancy providing wide variety of Quality Assurance, auditing and training services for Medical Devices and Pharmaceutical Industries.

What is Good Clinical Practice (GCP) and ISO 14155?

Definition from EU Directive 2001/20/EC, article 1, clause 2: Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. More

What is ISO 13485?

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. More

Deming's 14 principles in clinical

trials project management