Regrettably they have generally suffered from being: Over the last 100 years, there have been many different initiatives. Additionally it is not the only way of improving Quality. It is required for the CE Mark of Medical Devices. ISO 13485 is the Quality Management Standard for Medical Devices. The requirements are well tested and help improve operations, productivity and profitability.Ĭlick the following links for more specific information: For CE Mark of Medical Device/s, the business will require ISO 13485 Certification.Ĭontact us today to also benefit from ISO 13485 certification and accreditation with increased operational efficiency. ISO 13485 Certification assists Medical Device related Organisations in achieving their aims & improving their business by helping them to manage & improve (rather than fire-fight).
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