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GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have enacted that pharmaceutical and medical device companies must follow GMP procedures and have their own criteria that correspond with their legislations.

Most foreign health authorities require a manufacturer to present a Certificate of Free Sales (CFS) from the country of origin or the European Union (EU) as part of the requirement for the medical devices import certificate in their territories.

Medical device and IVD equipment manufacturers mostly operate within the boundaries of a quality system, which complies with one or more of the international harmonized standards. Those systems are subjected to audits as part of the certification process and regulatory compliance. Internal audits performed by external bodies are a great way to control and maintain QMS activities.