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5 Key Requirements of the ISO 13485 Medical Device Standard

ISO 13485 is the international standard for medical device quality management. The ISO develops explicitly to help medical device businesses ensure their devices’ quality, consistency, and safety. Achieving the ISO 13485 Certification demonstrates that your business complies with regulatory requirements consistently. Including legal and industry-specific regulations increases the acceptance of your products or devices. The certification is still not mandatory for medical device companies, but without it, you may find it challenging to keep up in the market and expand your business.

Related: ISO 13485 QMS for Medical Devices

5 Key Requirements Underlined by the ISO 13485 Standard

The ISO 13485 standard underlines its requirements in eight sections. The first three sections are generic and introductory. The following five sections highlight the critical requirements for QMS (Quality Management Systems) medical devices. Here they are:

  • QMS Requirements
  • Management Responsibility
  • Resources Management
  • Product Realization
  • Performance Evaluation
5 Key Requirements Underlined by the ISO 13485 Standard

1). QMS Requirements

Determining the scope of your QMS, establishing its structure, and deciding how it will be integrated into your medical device manufacturing process. You should also create and maintain proper documentation of your operations and the QMS.

2). Management Responsibility

Proactive participation and commitment of the management team in developing, executing, and maintaining the QMS.

3). Resources Management

Determining the resources needed, including personnel, infrastructure, training programs, communication, etc., ensures the QMS is implemented correctly and the planned objectives are achieved.

4). Product Realization

Determining the methods of designing, purchasing, developing, reviewing, measuring, and controlling the products or devices.

5). Performance Evaluation

Regularly monitor the QMS to ensure it is operating competently, identifying issues and taking necessary actions to improve it.

Key Takeaway

Meeting the requirements with a well-implemented QMS is not enough to get the ISO 13485 Certification. There is more to the process. You need to perform an internal audit to ensure all the methods are effective and identify the nonconformities to undertake corrective or preventive measures. When you are assured about your medical device business’s compliance with the ISO 13485 requirements, you can apply for the certification and get certified.