Medical Device Quality Management System

What is a medical device quality management system?

A quality management system (QMS) is a set of documented processes, procedures and responsibilities for managing and achieving specific goals in an organization. A QMS helps to align an organization’s purpose and strategy with meeting customer and regulatory requirements to continually improve its effectiveness and efficiency. An organization can include any process in their QMS which they want to apply quality management principles to, e.g. development, human resources, and purchasing.

You should always try to establish your QMS as early as possible. This is especially important for medical device manufacturers, because the QMS needs to incorporate all relevant regulatory requirements that need to be considered when developing a medical device. It is much more efficient if you are aware of all requirements that you need to comply with early on, so your development can accommodate them.

You can establish your QMS to comply with specific standards, e.g. ISO 13485 for medical devices, in which case you can get your QMS certified to that standard. In this case, you have to maintain the certification – certification is not a one-off exercise.

Remember, A QMS should be tailored for the type, size and the role of your organization.

What are the important stages of quality management?

At the heart of quality management is continuous improvement. The Deming Wheel/Shewart Cycle nicely summarises an iterative approach to improving processes. This is also known as the PDCA principle of plan-do-check-act.

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Can you bring a medical device to market effectively without a QMS?

It is mandatory to have a QMS in place if you are developing a medical device but it is not mandatory that your QMS is certified. However, it is always easier to prove compliance if your QMS is certified.

The routes to certification differ depending on the regulatory requirements of your target market. You have the option to certify your QMS against the harmonized (in EU) or consensus (in USA) standards which gives the manufacturer “the presumption of conformity” with the legislation. An example of such a standard is ISO 13485.

Please note: The authority certifying the QMS will still do so according the applicable legislation, even if the QMS is ISO 13485 certified.

Medical QMS Software

If you don’t have experience setting up a QMS, you might consider using software marketed for this purpose. However, a QMS should always be tailored for the type, size and the role of your organization – there is no “one-size-fits-all” solution for a QMS. Even if you want to use QMS software, you still have to start with drafting the exact processes that you need in your organization taking into account the regulatory requirements that are specific to you. Thereafter, you can use QMS software, e.g. Intland Software, to support what you need to do, but you shouldn’t rely on it completely.

QMS software also won’t take into account your existing processes or your ways of working. So, even if you use software to set up your QMS, you will still have to do some level of customisation.

Ultimately, your QMS should work for you so it should be tailored to the role and size of your organization. So, it is best to partner with a specialist like ArrowFast who can quickly create a QMS tailored for you.

What are quality system requirements?

The requirements for a medical device QMS are usually specified in the regulations that apply to your target market. However, many countries around the world have regulatory requirements for a medical device quality management system that are covered (in great majority) by the ISO 13485 standard. This standard specifies the requirements for a QMS targeted to the medical devices industry and that applies throughout the medical device’s lifecycle. Therefore, it is often in your favour to comply with ISO 13485.

The ISO 13485 standard is not mandatory and does not itself require that organizations be certified in order to apply the standard. Many organizations can benefit from implementing the standard without undergoing the certification process. However, being ISO 13485 certified is the easiest way to demonstrate to regulators and customers that you have met the requirements of the standard.

Who is responsible for using quality management system?

Every person involved in the organization participating in any part of the medical device lifecycle must use the medical device quality management system.

What does a medical device quality manager do?

A medical device quality manager is usually the person in charge of quality in general. In summary, they ensure that the QMS is properly established for the type, size and role of the organization, that all products and services delivered by the organization comply with the established QMS, that the correct roles exist (as required by regulations), that any issues are properly resolved and that there is continuous improvement of the QMS.

The quality manager is also responsible for ensuring that the QMS is certified, if this is required, and for ensuring that the certification is kept up-to-date.

Which international regulations apply to a medical device QMS?

The regulations applicable to medical device QMSs depend on the target market. However, many target markets use the ISO 13485 standard which specifies the requirements for a medical device quality management system that can be applied in the different phases of the life-cycle of a medical device.

ArrowFast works with all stages of the medical device lifecycle. We use our own QMS on a daily basis in the course of our work. So, we understand that a QMS cannot simply be compliant, it must be usable. Contact us at regulations@arrowfast.tech and let’s discuss how we can create a QMS that works for you.

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