Safety in quality is very important in the medical devices space. Regulatory requirements are becoming increasingly stringent throughout the product lifecycle, with a focus being placed on competence, requirements, and design validation activities. In addition, there is a larger expectation for organizations to not only demonstrate product compliance, but adherence to their own quality management processes and ensure that they follow best practices for what they do.

ISO 13485 management review

ISO 13485:2016 is designed to take into account changes in technology, regulatory requirements and expectations.

Certified management systems need to be reviewed to ensure they are not only performing but revised to incorporate the current information relevant to the market, customer, and regulatory situation.

How to participate in an ISO review

A review can be in the form of an audit, investigations arising from issues, or an improvement opportunity and have varying levels of outlook.

A comprehensive ISO 13485 audit will cover everything an organization needs to know to understand the current situation. It will cover key concepts, including ISO 13485 certification and a thorough review of all quality management systems, policies and procedures in line with applicable regulatory landscapes.

ISO 13485 requirements

The specific nature of the medical device industry requires increased and detailed consulting to ensuring consistent product quality and regulatory understanding. ISO 13485 contains requirements, the fulfilment of which contributes to the solutions:

  • Implementation and maintenance of a quality management system
  • Development of appropriate documentation
  • Applying a risk-based approach
  • Ensuring personnel competence
  • Efficient management of resources
  • Analytical work aimed at continuous improvement and quality enhancement

Distinct Compliance Engineering has extensive experience in the field of ISO certification and implementation of medical devices quality and safety management systems.

If you would like to know how we can help achieve your ISO compliance, or ISO13485, goals contact us.