ISO 13485 is a quality management system specifically designed for medical device manufactures, designers and developers which is similar to US FDA 21 CFR 820. Implementation of ISO 13485 helps an organization to keep the quality and consistency of medical devices, moreover it is an assurance to their clients about the quality of their product. ISO 13485 is a mandatory requirement for CE Marking which is the key to enter in to the European medical device market.
LMG provide complete assistance in ISO 13485 implementation which includes,
The Cost for ISO 13485 : 2016 certification vary from organization to organization, it depends on various factors like -
If interested, Please contact us with detailed information for an approximate budgetary quote.