What Are ISO 13485 Medical Devices?

What Are ISO 13485 Medical Devices?

ISO 13485 medical devices are products certified by the International Organization for Standardization. The certificate shows that the devices are reliable and that they are designed and manufactured following established rules and regulations. Also, it is proved that the devices meet international standards of quality and functionality.

What are ISO-certified devices?

The devices manufactured following ISO 13485 standards are called ISO-certified devices. They are reliable because they match international standards. Also, they are always high in demand. Since the demand for quality medical devices is increasing day by day, markets are looking at manufacturers who can produce quality devices. But the government agencies want to make sure that the manufacturers don’t compromise on quality just to save money.

How to find ISO-certified medical devices?

When you go to buy medical devices, you should look for ISO certification. All ISO 13485 medical devices have ISO certification. It is a seal of authority and reliability. These products pass all quality tests and they are used by leading hospitals and clinics. It is for this reason that medical produce manufacturers are advised to obtain ISO certification.

Businesses that need ISO 13485 certification

1. Medical device manufacturers

These are big brands and they don’t work without certification. Also, they are always punctual with their certification. They understand the value of ISO certification and for this reason, they waste no time in obtaining the necessary certification and renewing the certification on time. They stick to international standards because they want to capture the medical sector.

2. Contract manufacturers

These are small manufacturers working for big brands but it doesn’t mean that they are free from the clutches of law. Since they play a crucial role in producing ISO 13485 medical devices, they also need ISO certification. They get contracts only when they prove their commitment to international standards in manufacturing and supplying medical devices.

3. Distributors and importers

Importers of medical devices need ISO 13485 certification to prove that they are capable of handling critical healthcare products. In other words, they get an import license to buy medical products from world markets only when they have the necessary certification.

4. Service providers

Companies involved in the maintenance, installation, and repair of ISO 13485 medical devices need ISO certification. This certification helps them get big contracts. With the necessary certification, they can prove that they comply with all rules and regulations. Also, they can use ISO certification and marketing of their services.  

Featured Post

Maybe You Like

Contact Us
Share Post :