ISO 13485 Certification For Medical Device , Equipment & Instrument manufacturing & Service Companies

ISO 13485 Certification For Medical Device , Equipment & Instrument manufacturing & Service Companies

200,000.00 (Incl. of GST)

ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.The medical devices industry is one of the most highly regulated sectors in the world. Significant quality systems and product requirements must be satisfied to ensure the medical devices produced are fit for their intended purpose.

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ISO 13485 is generally harmonized with ISO 9001 a principle difference however is that ISO 9001 requires organizations to demonstrate continual improvement

Where is ISO 13485 required only that the certified organization demonstrate the quality system is effectively implemented and maintained while going for the production of all types of medical devices and instruments?

ISO 13485 controls in the work environment to ensure product safety while during the production

ISO 13485 focus on risk management activities and design control activities during the product development of any medical device or instruments

ISO 13485 specific requirements for inspection and traceability for implantable devices

ISO 13485 specific requirements for documentation and validation of processes for sterile medical devices manufacturing and all types of medical devices and instruments manufacturing



Client information required for the certification process

M initial discussion about existing practices to evaluate

A complete gap analysis of your company with respect to your certification requirement

A custom return mandatory certification documentation training and complete pre-assessment

Documentation training and Audit will be done for the purpose of knowledge to all the staff in the manufacturing sector of medical devices and instruments

ISO 13485 enhances the ability of the organization to meet customer and regulatory requirements

ISO 13485 helps organizations capability to address the product safety and effectiveness

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