ISO 13485 Medical Device Quality Management System

The ultimate global benchmark for quality management practices specific to the medical device industry and a critical framework for boosting your organization’s customer satisfaction.

What is ISO 13485?

ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) in the medical device industry. The standard is designed to help organizations develop and manufacture medical devices that are safe and effective for their intended use. It is based on the ISO 9001 standard, but with additional requirements specific to the medical device industry. Some of the key requirements of ISO 13485 include the need for organizations to have a documented QMS, to establish clear procedures for the design, development, and production of medical devices, and to ensure that their products meet applicable regulatory requirements. In addition, ISO 13485 also requires organizations to have a system in place for monitoring and improving the effectiveness of their QMS.

ISO 13485 Benefits

Improved product quality and safety

By implementing a quality management system based on ISO 13485, organizations can ensure that their medical devices are designed, developed, and manufactured to a high level of quality and safety. This can help to reduce the risk of defects and other issues, which can improve patient outcomes and reduce the likelihood of recalls and other problems.

Increased customer satisfaction

By implementing ISO 13485, organizations can demonstrate to their customers that they are committed to producing high-quality medical devices and providing good customer service. This can help to improve customer satisfaction and loyalty, which can in turn lead to increased sales and market share.

Greater regulatory compliance

ISO 13485 includes requirements that are specific to the medical device industry, such as requirements for documentation and design control. By implementing the standard, organizations can ensure that they are meeting these requirements, which can help them to avoid regulatory penalties and other problems.

Increased efficiency and cost savings

Implementing ISO 13485 can help organizations to streamline their processes and eliminate waste and inefficiency. This can lead to cost savings and improved efficiency, which can help organizations to stay competitive in the marketplace.

Enhanced market access

In some cases, ISO 13485 certification may be required in order for organizations to sell their medical devices in certain markets. By implementing the standard, organizations can demonstrate that they meet the necessary requirements and gain access to these markets.

ISO 13485 Services

Encompass Consultants has worked for many years to perfect our ISO 13485 services.

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For organizations seeking expert assistance in achieving ISO 13485 compliance, our team of consultants can guide you through the entire process, from initial planning to final certification.

Internal Auditing

For organizations that have already achieved ISO 13485 certification or are facing an upcoming customer audit, we offer expert internal auditing services to provide an objective evaluation of your organization's compliance with the ISO 13485 standard.


Frequently Asked Questions

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How long is ISO 13485 certification valid for?
What are the key requirements of ISO 13485?

Encompass Consultants

Encompass Consultants, is a father and son owned business. Founded with the intention of helping organization’s navigate the complex world of compliance. We pride ourselves on our personalized approach and our commitment to providing high quality services to each and every one of our clients. Whether you are a small business owner or a large corporation, we have the knowledge and expertise to assist you with all of your compliance needs.

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