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Trusted ISO 13485 Consultant In India | 4C Consulting

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Medical device QMS. 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, rehabilitation of illness and disease or other medical conditions.

Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.


ISO 13485



Scope & Application


ISO 13485 is important to designers, manufacturers, and distributors of medical devices. In addition, suppliers and service providers can enhance an organization's marketability as more and more manufacturers require certification in order to do business with a vendor.


It is applicable to:

  • Manufacturing of medical devices (MD) or in vitro diagnostic products (IVD)
  • Manufacturing of reagents or substances for use in IVD or MD(for pharma and diagnostic purpose
  • Medical device Traders.


Iso 13485 Requirements



GENERAL REQUIREMENTS


The ISO 13485 standard contains specific requirements for manufacture, installation and servicing of medical devices, which strongly focus on the compliance of EU Directives for MD or IVD such as:


  • Provision of technical documentation (medical device file / technical product file)
  • Specific design & development requirements
  • Implementation of a risk management process to product development and product realization.
  • Validation of processes.
  • Health, safety and staff hygiene requirements
  • Change management, market observations and procedures for product recall
  • Compliance with statutory and regulatory requirements
  • Effective product traceability and recall systems.



ISO 13485


DOCUMENTATION REQUIREMENTS


Here are the documents needed for compliance with ISO 13485:2016


  • Quality policy and Quality objectives.
  • Medical Device Quality management system manual.
  • Mandatory procedure for Medical device process management.
  • Requirements for infrastructure and maintenance activities
  • Requirements for work environment
  • Arrangements for control of contaminated or potentially contaminated product
  • Process for risk management in product realization
  • Procedure and records for servicing of the medical device, service validation.
  • Procedure and records for data analysis and corrective actions



Benefits Of Iso 13485 Implementation


  • Increase access to more markets worldwide with certification
  • Outline how to review and improve processes across your organization
  • Increase efficiency, cut costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical devices
  • Meet regulatory requirements and customer expectations


Why Was Iso 13485 Revised?


All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations.


What Are The Key Improvements In Iso 13485:2016?


The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain. Furthermore it now includes stakeholder’s role, improvement in feedback processes and traceability.

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