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ISO 13485 Certification – Medical Devices-Quality Management System

Get your ISO 13845 certification for your medical devices’ lifelong quality management system by a leading ISO certification company worldwide.

What is ISO 13485 Certification?

Public health and safety can’t be neglected in the medical line industries, so an ISO 13845 standard was developed.

ISO International Organization for Standardization developed ISO 13485:2016 a Medical Devices QMS standard. Considering the population in any country, public (human) health is one of the major concerns of the government. So this is the most outstanding standard adopted by the organization to take their business to next level. An internationally developed ISO 13845 is a standard that specifies the guidelines and requirements of the quality of medical devices and the medical sector. It is a commitment of an organization that the devices used are all up-to-date with current technologies. The medical field is witnessing continuous growth whether it can be in terms of technology development or in the quality they provide.

ISO 13485:2016 certification for a company/organization is proof that you are in safe hands and your health is very crucial for them. In many markets and countries, only ISO 13485 certification is not sufficient for approval for selling or using medical devices. They need legal approval from their local regulatory bodies.

Benefits of ISO 13485 Certification

The advantages of ISO 13485 Certificate are not just up to the limit but it is further in long run for an organization or a firm ready to accept the quality standard for medical devices/services. It can be considered as a tool for excelling in the market by providing qualified services to the public. Some benefits of ISO 13485 Certification are:

1. Meeting regulatory requirements of the local authority as well as the standard.

2. Legal compliance in quality.

3. Improved technology and quality.

4. Time-saving process.

5. Accurate results.

6. Customer satisfaction.

7. Gaining the trust of stakeholders.

8. Proven business creditability.

9. Increased sales revenue and opening of new markets.

10. Guarantee of product’s safety and steadiness.

What are the requirements of ISO 13485 Certification?

The ISO 13485 standard requires some specific requirements to be followed for implementing, installing, and providing products and services.

  • Determining the plan and need in the medical devices.
  • Identification of quality management system in the medical process and procedures.
  • Documentation is required to fulfil the need of the standard.
  • Regular maintenance of medical devices.
  • Timely sanitization of devices.
  • A yearly internal audit of an organization.

Why you need ISO 13485 certification?

ISO 13485 is a certificate for QMS for medical devices organizations that guarantee that the processes in the Organization are compliant and following requirements, guidelines, and regulations. To gain the benefits of ISO 13485 Medical Device and build the image in the market by providing quality devices and keeping the customers’ needs, safety and health at high concern, application of this standard is a must.

Which Organization needs ISO 13485 Certification?

An organization or a firm may be a supplier, distributor, manufacturer, retailer, or any other related to or deal in medical devices or types of equipment need to have this ISO 13485 certification. In some countries, ISO 13485 certification is made mandatory for medical devices. It is a valuable certificate to keep the customer safe in hospitals, clinics, and other medical centers.

Strength of Ascent EMIRATES

  • Worried about Medical Devices’ safety? NO need Ascent helps you in assuring that the medical products used are safe by achieving an ISO 13485 certificate.
  • Ascent helps to gain the certificate without the burden of unnecessary documents to your organization.
  • Ascent has qualified professions that help you resolve various problems to the conformity of ISO 13485 accreditation.
  • Ascent works 24X7 for the welfare of their customers and clients with a simple motto “No extra cost than the offered cost”.
  • Ascent EMIRATES always offer- “Guide to Quality”
  • Ascent explains the importance and implementation of the ISO 13485 standard and guides you throughout the process to achieve the standard.

There is no compromise when it comes to health safety, that is why you can trust the Ascent EMIRATES by providing reliable and innovative solutions to your problems. Get in touch today for early access to safety.

Frequently Asked Question

What are class 1, 2, 3 medical devices?

Medical devices according to FDA or as per EU Regulations are divide into various Categories based on Product Risks eg. CAT 1 / CLASS I (Devices with low-moderate risk to the consumer requires general control; CAT 2 / Class II (Devices with moderate-high risk requires special controls); CAT 3 / Class III( Device with high risk supporting life or sustaining life).

What is the cost of applying for ISO 13485 certification in India?

The cost of this standard is apparently a little higher than the cost of other standards related to quality management as it is a very crucial standard dealing with the safety of medical devices and consumers’ life. It depends on the type of device you are dealing with.

Is ISO 13485 certification mandatory?

ISO 13485 Certification is mandatory in some countries for some of the kinds of products being dealt by some companies types. But obtaining ISO 13485 is safer to deal with medical products as the products are related to health concerns.

How long does it take to acquire ISO 13485 certification

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How long ISO 13485 certification valid for?

ISO 13485 Certification is reviewed for a timeline of 3 years. When an ISO standard is up for revision, they generally announce well in advance and require a technical committee to work on it.

What is the difference between ISO 9001 and ISO 13485?

ISO 9001certification is an international standard for Quality Management systems for all types of industries whereas ISO 13485 certification is a Quality Management System for medical devices.

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