ISO 13485 Certification

About ISO 13485 Certification

The international standard ISO 13485 provides requirements particularly to improve the quality management system of the organizations that provide medical devices and equipment. It specifies control measures to reduce operational errors in the manufacturing process and system. ISO 13485 Certification Also, this standard ensures the continual improvement in the quality of medical equipment.

ISO 13485:2016 Version

This is the current version of the ISO 13485 standard, developed with a process approach to reduce the operational errors and risks in the management system. As ISO 13485:2016 is proposed with a high-level structure and PDCA cycle, it can be integrated with other ISO management system standards. Also, its risk-based thinking approach helps the organizations to meet their customers’ requirements consistently.

What is a Medical Device?

A medical device is a device, such as an instrument, machine, implant, or in vitro reagent, that is used to diagnose, prevent, or cure diseases or other medical conditions. Examples of common medical devices are:

  • surgical instruments
  • wheelchairs
  • hospital beds
  • CT scanners
  • catheters
  • defibrillators

What is ISO 13485 Certification?

Companies that achieve ISO 13485 certification ensure the safety of professionals and patients in clinics, hospitals, and other medical facilities. This standard specifically covers the requirements to establish and maintain a quality management system for organizations that design and manufacture medical devices and equipment. It is required by the U.S. Food and Drug Administration for medical device manufacturers who require ISO 13485 Certification before shipping products to the U.S.

Who needs ISO 13485 Certification?

ISO 13485 certification is necessary for quality management systems in medical device companies. Organizations involved in the design, production, installation, and servicing of medical devices and related services should obtain ISO 13485 certification. ISO 13485 certification can also be utilized as a baseline of quality assurance by regulatory authorities and certifying organizations when performing compliance evaluations. ISO 13485 certification helps organizations get recognition as more respectable, trustworthy providers because it is an internationally recognized standard of quality and safety for medical device manufacture.

What is the ISO 13485 Certification Requirements?

To achieve ISO 13485 certification, an organization must meet specific requirements of ISO 13485 standards. ISO exhibits several clauses that are applicable to medical devices and ISO procedures. ISO 13485 certification ensures that a medical device company is ISO-compliant, and ISO procedures are incorporated in the organization. ISO 13486 certification requirements include:

  • Review of Design Controls
  • Development and Management of ISO-Compliance Documentation
  • Quality Risk Analysis
  • Peer Review as Evidence of ISO Compliance
  • Identifying ISO-Mandated Documents
  • ISO Training Plan
  • Internal ISO Audit

Following ISO 13485 certification requirements ensures that your company meets the minimum patient safety, health care quality, and regulatory requirements. This standard specifically focuses on an organization’s ability to follow ISO procedures in order to produce medical devices for human use.

ISO 13485 Certification

Who can apply for ISO 13485 Certification?

Regardless of size, the requirements of the ISO 13485 certification standards are applicable to all companies/industries that manufacture and deliver medical devices and equipment. Additionally, ISO 13485 certification applies equally to the industries that provide related services.

Benefits of ISO 13485 Certification

  • Improvement in quality and safety of medical devices
  • Reduces wastes and operational errors
  • Demonstrates compliance with local regulations
  • Promotes customers confidence and satisfaction
  • Strengthens the relationship with stakeholders
  • Creates new business opportunities on a global scale

Why choose IAS to obtain ISO 13485 Certification?

Although the International Organization for Standardization (ISO) establishes and publishes the ISO 13485 standards, they do not perform certification. Therefore, organizations turn to third-party certification bodies to obtain ISO 13485 certification such as IAS. IAS is a leading ISO 13485 Certification body in the United States and assists companies in ensuring that their ISO 13485 quality management system is effective by conducting conformity assessments with certified experts who are experienced auditors. IAS audits your operations against the standard’s requirements to ensure you properly obtain ISO 13485 certification in a timely manner.

Once you successfully achieve ISO 13485 Certification through IAS, you can check the status of your certificate by visiting our ISO 13485 Certification Search Page!

ISO 13485 Certification Cost

The ISO 13485 certification cost depends on the size and complexity of the company and its products. The following are some factors that determine the total ISO 13485 certification cost:

  • The size of the company
  • Number of locations
  • Products and services provided by the company
  • Number of employees

Thus, the ISO 13485 certification cost can vary greatly and it is important to contact IAS for a detailed quotation. IAS provides the lowest market rates for ISO 13485 certification in the United States. To learn more about the ISO 13485 certification cost, contact us today for a free consultation!

How to contact us?

There are plenty of ways to reach us.

  • Visit our website –
  • Send us your inquiry through our website
  • Drop a mail to [email protected]
  • You can also fill out our ISO 13485 Certification application form and send it to us.

Click here to learn more about our ISO 13485 Certification audit procedure and the ISO 13485 Certification process! Also, see the ISO 13485 certification frequently asked questions page to learn more!