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ISO 13485

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ISO 13485

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ISO 13485 Standard is represented for Manufacture of Medical Devices. It is a management system specially used in developing and manufacturing various medical devices. ISO 13485 Standard has a primary objective of facilitating harmonized medical devices with its regulatory requirements.

REQUIREMENTS OF ISO 13485

Here is the standard list of requirements containing in various phases of manufacturing, installation, services and calls are listed below:

  • Enhance and implement Quality Management System
  • The risk management approach for both product development and product realization
  • Validation of various Processes
  • Statutory and regulatory requirements with necessary compliance
  • Effectiveness in product traceability and recall systems

ELIGIBILITY OF ISO 13485

ISO 13485 Standard contains various application requirements which are essential for any organization irrespective of its size. An organization with operations at any tier related to medical devices and pharmaceutical supply chain system are eligible for ISO 13485 Standards.

This standard is specifically relevant to a variety of manufacturers who are willing to demonstrate the applicable regulatory requirements and also the organizations where service support of medical device manufacturers is available can also get the benefits of ISO 13485.

BENEFITS OF ISO 13485

ISO 13485 Standard Certification helps in achieving the success step towards compliances in coordination with European Requirements.

  • Increase the probability of safety and effective medical device manufacturing system
  • Meet the regulatory requirement standards
  • Work up to customer requirements with a solemn goal of customer satisfaction
  • Help in monitoring the effectiveness of the supply chain management system
  • Get into the major market with one audit file to engage with the standard globally
  • Improve risk management techniques within the organization
  • Assist with design controls to the customers in the development and implementation of the products
  • Improve efficiency in obtaining market clearance among customers
  • Approval needs to meet marketing goals and increasing the sales
  • Ensure compliances requirements as per the organization needs
  • The potential gain into the international market standard

ISO 13485 is well-known as a Stand-alone QMS Standard. It is derived from the ISO 9000 Quality Management Standard Series which is internationally renewed. ISO 13485 probably adapts ISO 9000 Standard process-based model for regular use in the medical device manufacturing environment.

ISO 13485 Standard is written to support various aspects of medical device manufacturers in design, develop, maintain, production, installation, and delivery of the medical devices. It ensures the quality management system and safety of their solemn intended purposes. It also establishes the effectiveness of the process.