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ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. Annex B of the ISO 13485:2016 standard includes a comparison with ISO 9001 for reference

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Vantage Care Apothecary reduced inventory and time spent on inventory management tasks, while improving pharmacy performance. Our flu vaccine pre book calculator helps you determine the right flu vaccine brands, presentations and quantities for the 2020 2021 season. Sustainable Technologies, a Cardinal Health business, is focused on single use

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Personal Protective Equipment (PPE) testing and certification from SGS ensure your products comply with Regulation, 2016/425. PPE is considered to be any item designed to be worn or held by an individual for protection against one or more safety hazards.

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To sell gloves as Category II PPE, to protect against mechanical risks, they must meet the EN 388 and EN 420 standards. Manufacturers, or their authorized representatives, in the European Community must also submit technical documentation, including product samples for testing, to a Notified Body for EU type examination under the EUs Personal Protective Equipment (PPE) Regulation, 2016/424.