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ISO 13485

21 Dec 2021

ISO 13485

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The medical device industry is coming under increased scrutiny for their manufacturing processes. Medical device product recalls are becoming more common, and this is putting the entire industry under a microscope. You may have your own thoughts on the matter, but there are some clear-cut ways to show that you are doing things correctly when it comes to quality systems. ISO 13485 is a standard which applies to medical device manufacturers worldwide, covering all stages in the manufacturing process from design and development. This blog will provide more information on ISO 13485 and its requirements.

What Exactly is ISO 13485?

ISO 13485 is an international standard for medical device design and development which specifies requirements for a comprehensive quality management system in order to ensure that products conform to customer and regulatory requirements. In other words, ISO 13485 is a quality management system standard that was specifically created for the medical device industry. It helps companies ensure that their products are safe and compliant with regulations.

ISO 13485:2016 – What Does it Mean?

The latest version of the standard was officially released at the end of 2016. ISO updates the standards every few years in order to keep up with the latest trends and issues within the industry. This particular update provides more detailed requirements and guidance on risk management, design verification, and product validation. The update of ISO 13485 is not particularly extensive but does highlight some key areas where there have been changes in medical device regulation over the past few years.

What are Medical Devices?

Medical devices are products which are used for the diagnosis, treatment, mitigation, or prevention of disease. They can also be used to diagnose pregnancy, monitor vital signs, and more. Some examples of medical devices are the following:

  • Catheters
  • CT Machines
  • Anesthesia equipment
  • Surgical instruments

ISO 13485 also applies to devices which are related to in vitro diagnostic (IVD) medical devices. IVDs are products that are meant to test bodily fluids like blood, saliva, and urine. They are used to help diagnose diseases and conditions.

Why is ISO 13485 Important?

ISO 13485 is important because it helps medical device manufacturers demonstrate their commitment to quality and safety. It provides a framework for implementing a quality management system, which can help ensure that products meet customer and regulatory requirements. In addition, ISO 13485 helps companies to stay competitive by providing a framework for continuous improvement, risk management, and business process management.

Who Needs to Comply with ISO 13485?

ISO 13485 applies to medical device manufacturers who want to demonstrate their compliance with regulatory requirements. It includes the processes involved in the design and development of medical devices. If you are a medical device manufacturer, it is important to understand and comply with the requirements of ISO 13485.

How Can I Comply with ISO 13485?

In order to comply with ISO 13485, you will need to establish a quality management system that meets the requirements of the standard. This system should cover all stages in the medical device development process, from design and development to production, installation, and servicing. In order to comply with ISO 13485, you will need a certification body to audit your company’s quality management system. This is important because it helps companies demonstrate their commitment to complying with applicable requirements.

ISO 13485 Requirements for Medical Device Manufacturers

ISO 13485 has specific requirements which must be met by manufacturers in order to be certified. These include things like ensuring that the organization is compliant with all local laws, document and manage risks appropriately, maintain an adequate quality system, ensure equipment is calibrated and tested, prove employees are competent, and more.

The standard is designed to be applicable to all types of medical devices, including Class I, II, and III devices. The ISO 13485 standard also applies to manufacturers of medical device components and sub-assemblies.

Classes of Medical Devices According to the FDA

Medical devices are classified under three categories according the US Food and Drug Administration:

  • Class I – These devices are low risk and do not require premarket approval or special controls. These include medical devices such as elastic bandages, adhesive bandages, and disposable gloves.
  • Class II – These devices generally pose a greater risk to patients who use them and therefore have more stringent requirements for approval. An example of a Class II device would be an ECG machine.
  • Class III – These devices are those that pose the greatest risk to patients and require extensive testing and approval before they can be marketed and sold. Examples include replacement heart valves, pacemakers, and surgical lasers.

How Can ISO 13485 Help My Organization?

If you are a manufacturer of medical devices or components, ISO 13485 can help you to ensure that your products are safe and compliant with all applicable regulations. The ISO 13485 standard provides a framework for establishing and maintaining a quality management system, which can help you to systematically manage your quality processes. A well-implemented quality management system can help you to reduce the likelihood of product recalls, improve customer satisfaction, and protect your reputation.

Advantages of ISO 13485

The key benefits of implementing ISO 13485 within an organization include:

  • Improved quality and safety of products
  • Reduced manufacturing and product development costs
  • Increased customer satisfaction
  • Greater credibility in the market
  • Demonstration of due diligence to regulators

It is important to note that the benefits of ISO 13485 are not limited to the manufacturers. Customers and other stakeholders can also benefit from it, including:

  • Increased patient safety due to higher quality products
  • Improved confidence in the manufacturer’s product through effective audits
  • Greater marketability due to improved quality management systems
  • Demonstrated commitment to manufacturing best practices by manufacturers
  • Increased likelihood of achieving business aims, such as early implantation and quicker return on investment

ISO 13485 Certification Process

In order to be certified to ISO 13485, you will need to undergo an audit of your quality management system by a third-party certification body. The certification body will review your system against the requirements of the standard and issue a certificate if it is found to be compliant.

The ISO 13485 certification process can be lengthy and costly, so it is important to make sure that your organization is ready for it before you begin. It is also important to ensure that your quality management system is maintained and updated on an ongoing basis, in order to maintain your certification.

ISO 13485 Audit

An ISO 13485 audit is a comprehensive review of your organization’s quality management system against the requirements of the ISO 13485 standard. The audit will be conducted by a third-party certification body and will include an assessment of your system documentation, processes, and performance.

The ISO 13485 audit process typically includes the following steps:

  1. Pre-visit Review – A pre-visit review will be conducted prior to the actual audit. The aim of this step is to identify any gaps in your current system documentation and processes, as well as to answer any questions that you may have about ISO 13485 certification.
  2. Site Visit– During the site visit, auditors will review your organization’s policies, procedures, and work instructions. They will also conduct a thorough walk-through of your facility to ensure that it meets all applicable requirements outlined in the ISO 13485 standard.
  3. Preparation for Audit Report– Once the audit is complete, the auditors will prepare an audit report that identifies any areas of non-compliance with the requirements of ISO 13485 and details any corrective actions that may be required for your organization to become compliant.

Are your ready for ISO 13485 certification? Contact us today for a free consultation!

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