[GUIDE] ISO 13485 for Medical Device Development

September 8, 2022 Kenzie Jonsson

ISO 13485

In this blog post, we will cover key components of the important medical device standard ISO 13485 and cover steps for successful adherence. 

In the complex world of medical device development, teams not only face challenges of innovation, but also a shifting regulatory environment and evolving standards.

Balancing the competing interests of customers and stakeholders with the guidance and regulations from different entities across global boundaries presents challenges that even the most organized and methodical teams may struggle to meet.

In this environment, systems thinking can greatly improve the ability of medical device development teams to get products from the idea stage to market. By breaking down complex problems into manageable pieces, teams can better evaluate their systems and streamline and strengthen processes.

Using an applied systems approach will also help resolve inefficiencies in the development process and produce the outputs necessary for the design history file (DHF).

A growing number of organizations and teams are already pursuing a general systems approach by applying the guidance in ISO 13485:2016. This standard helps define a framework for the Quality Management System (QMS) for medical device development and pushes the development process naturally toward a systems approach. But for those teams that have not yet adopted the standard, adding one more document or piece of guidance to the overall process can feel like another layer of complication.

It doesn’t have to be. Adopting this standard can help standardize and systematize the medical device development process. Though it may look daunting at first, once adopted, ISO 13485 can streamline processes and position organizations for a better outcome with regulatory requirements.

RELATED: How to Executive a Successful Design Review When Building Medical Devices

The Purpose of ISO 13485

The standard was developed by the International Organization for Standardization (ISO) to outline the standard for a Quality Management System (QMS) for the design and manufacture of medical devices.

The ISO defines “medical device” as “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 or other medical conditions.” It is a stand-alone document designed for use by organizations of any size involved in any stage of medical device development, from design to production to installation to service of devices. Both internal and external parties can use the standard to support the auditing process.

ISO 13485 is the most common standard for quality management in the field of medical device development across the globe. Adoption of the standard indicates a commitment to the highest quality and safety across the development process, and it provides a foundation for QMS requirements.

While not required by all government entities, the standard does provide a good foundation for addressing regulations such as the EU Medical Device Directive and the EU Medical Device Regulation. In 2018, the FDA proposed a rule that would align US FDA 21 CFR 820 with ISO 13485:2016; this rule would make this standard the mandatory QMS for medical devices.

Note: The rule was set for release in 2019; however, as of December 2020, the rule was still forthcoming. Check for current guidance.

RELATED: Your Guide to Selecting a Medical Device Development Platform

Requirements for ISO 13485 Adherence

Though adoption of ISO 13485 may look complicated or daunting, in reality, adhering to the standard helps eliminate some of the ad hoc nature of requirements and systems in the medical device field.

With increasing worldwide adoption of ISO 13485 by both companies and government entities, the medical device industry should start to realize some harmonization and consistency of processes and systems. This standardization will help streamline the industry overall and allow important innovations a smoother and potentially faster route to market.

The requirements to obtain ISO 13485 certification start with a QMS. ASQ defines a Quality Management System as “a formal system that documents the structure, processes, roles, responsibilities and procedures required to achieve effective quality management.” The QMS must include documentation that defines the overall scope and implementation of the QMS; important documentation includes Quality Policy, Quality Objectives, and Quality Manual.

Bottom Line These documents should be sure to address customer requirements. In addition, organizations need to create mandatory and additional processes and requirements necessary for all stages of development. Examples of documents required by ISO 13485:2016 can be found here.

Key Takeaways from Our Complete Guide

  • ISO 13485 and systems thinking go hand-in-hand; teams will find that adoption of ISO 13485 directs them toward systems thinking.
  • Adoption of this standard will streamline processes and position medical device teams for better regulatory outcomes.
  • ISO 13485 is a stand-alone document; however, it closely aligns with ISO 9001:2008 and EN ISO 13485.
  • ISO 13485 and ISO 14971 are related, but ISO 14971 is more focused on risk management – the two standards can be used in tandem.
  • This standard is not mandatory; teams can develop a Quality Management System (QMS) without the standard as long as it meets regulatory requirements. However, adoption of the ISO 13485 will create a QMS that is ideally positioned to meet the requirements of various regulatory and legislative entities, including the EU.

Jama Software’s Complete Guide to ISO 13485 for Medical Device Development covers requirements for adherence, the difference between ISO 13485 and other medical device standards, and steps for successful adoption and certification.

Download The Complete Guide to ISO 13485 for Medical Device Development to untangle everything there is to know about this important standard.


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