Good Manufacturing Practices (GMP) is a part of the Quality Management System that helps ensure products are produced and controlled according to quality requirements. Companies must ensure that all procedures impacting the product’s identity, strength, quality,...
The benefits of a Quality Management System (QMS) are numerous and wide-ranging. A QMS will help any industry streamline its processes and improve the overall quality of its products and services. In the life sciences industry, a Quality Management System (QMS) is...
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of multiple regulatory authorities. Audits are conducted by Auditing...
The ISO 15189:2022 is an international standard that specifies the requirements for quality and competence in medical laboratories. The medical laboratory is essential to patient care since decisions on patient treatment are made based on laboratory results. The...
The ISO 13485:2016 is an international regulatory standard that specifies the requirements for Quality Management Systems (QMS) in the medical device industry. A QMS that meets the ISO 13485:2016 requirements demonstrates a commitment to quality and customer...
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