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What is ISO 13485?

Quality System for Medical Device and adopt a risk management approach to identify risk throughout the medical device product realization and such identified risks are managed to eliminate hazardous situations in medical device.

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Why to get ISO 13485?

ISO 13485 Standard implementation by Medical Device Manufacture also reduces trade barrier to enter into international market such as Europen Market & helps to meet Quality System requirement of European Medical Device Directives.

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How to get ISO 13485?

Organization need to implement the ISO 13485 standard and apply us for ISO 13485 certification. We will conduct 2 stage audit - 1st Docuemnt review audit & 2nd Process Audit. After sucessfull audit and closure of NCs certificate is issued.

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About us

We are one of the leading quality certification organizations offering a plethora of quality certifications (management system & product both) services to organizations of all nature and size. We are in the same filed from last many years. We believe in upholding highest standards of business ethics with complete commitment to total quality.

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