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ISO 13485 is an internationally published standard that defines requirements within quality management systems for manufacturers of medical devices and equipment. The main objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical devices sector. ISO 13485 has been based on the requirements of ISO 9001 and has the same structure in terms of clauses. The ISO 13485 standard, medical devices – quality management systems – requirements for regulatory purposes, is the basis for regulatory compliance in local and most export markets.  An ISO 13485 certification demonstrates your organization’s commitment to providing products and services that consistently meet medical industry customer and regulatory requirements.

ISO 13485 switches the focus from customer satisfaction and continual improvement to standardization of regulatory requirements for medical devices manufacturers.  ISO 13485 is suitable for all the organizations involved in the medical device lifecycle and looking for an improvement in the way it is operated and managed. In recent years, ISO 13485:2003 has become the worldwide reference standard for the companies dealing with medical devices.

Benefits of ISO 13485

  • It creates a competitive advantage

  • It ensures a consistent and effective approach to business management

  • It reduces risk factors by employing risk management techniques

  • It provides repeatability and consistency within the manufacturing processes

  • It engages top management involvement

ISO 13485:2003 Certification is becoming the preferred method for medical device manufacturers and their sub tier suppliers/contractors to demonstrate the intent to comply with applicable regulatory and statutory requirements. Medical device manufacturers who are placing their products on the market within the European Union will need to address compliance with the requirements of the applicable Medical Device Directive and the CE marking process.

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