W.H.O. says- “The medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or another similar or related article intended by the manufacturer to be, used alone or in combination for a medical purpose.”

Medical devices are used in many diverse situations, and without medical devices, ordinary medical procedures would also become challenging. These devices can be simple or complex medical devices that facilitate human needs. A thermometer is a simple medical device, and an X-ray machine is a complex medical device.

Machines are human-made, and they cannot be entrusted blindly. How can we decide which device is better than the other? Is there any way to discover the quality of medical devices?

Yes, we have ISO 13485 on medical devices.

ISO 13485, also known as Quality Management System for Medical Devices, is an internationally accredited standard that signifies the quality of medical devices. ISO 13485 is a standard derived from ISO 9001 Quality Management System QMS.

The organisation must demonstrate its capacity to supply quality medical products to meet customer requirements. It ensures the quality of products and services related to medical devices.

Every organisation must follow the regulatory requirements of ISO 13485, whether it deals with design and development, production, storage and distribution or any other organisation trading medical devices. Any organisation manufacturing medical devices or associated with them, such as a supplier, has to follow the requirements of ISO 13485 Quality Management System for Medical Devices.

It requires the industry to monitor, maintain and control the processes to establish a quality management system. It ensures effectiveness, control and maintenance of a quality management system, which is critical for delivering quality services and meeting customer requirements.

1. Product expertise: ISO 13485 ensures a quality management system that includes professionals and well-qualified technical specialists, which assures good quality products and services.
2. Access to the Global market: ISO 13485 emphasises quality and reduces risks, which makes it easier for companies to trust each other and acquire new customers. It is a sign of quality, and medical devices directly impact human lives, it guarantees the quality of product and services.
3. Service-oriented: It requires conducting internal audits to examine the operations and oversee the quality of products and services.
4. Patient safety: It ensures patient safety. It strives to deliver high-quality products and meet customer requirements while complying with all the regulations.
5. Cost reduction: It reduces the cost and aims at improving the processes and operations consistently to save time and money. It follows corrective and preventive techniques to build a quality management system.
6. Increase efficiency: It increases the efficiency and secures effectiveness, maintenance and control of the quality management system of the organisation.
7. Helps in expanding customer base: It helps in expanding the customer base of the organisation. It is a hallmark of trust and credibility and helps in acquiring potential customers.

1. It is a transparent system, as it offers a clear insight to the end user regarding the usage and quality of the device.
2. It follows a risk analysis approach to avoid discrepancy and promotes an effective quality management system.
3.  It strives to meet customer requirements and prioritises end-user safety and needs.
4. It offers a better risk management mechanism as it consistently traces products and services, which makes it easier to find errors and rectify them.
5. It provides a regulated framework, which helps the organisation to gain customers and business.
6. It requires the organisation to consistently conduct internal audits to examine the operations, which ensures the quality of the products and services.

There are Eight requirements for ISO 13845 Certification, and the first three requirements are general and introductory. The last five sections define the necessary requirements. These five sections are:

Section 4: Quality Management System

It requires establishing a Quality Management System for medical devices and following all the national and international regulations.

Section 5: Management responsibility

The organisation has to design a complaint redressal for the customers and effectively communicate all the objectives and policies within the management.

Section 6: Resource management 

It deals with resource management. It includes human resources as well as raw materials. An organisation must ensure that all the employees are well qualified and trained.

Section 7: Product realization 

It deals with the expansion of products and services and the formulation of strategies to carry out distinct business operations.

Section 8: Measurement, analysis and improvement

It requires monitoring and taking remedial actions to improve current business operations to meet customer requirements.

ISO 13485 helps in expanding the business and assures high-quality products and services as it is derived from ISO 9001, also known as Quality Management System.