ISO 13485 certification for the management of medical device quality management systems

Do You Need ISO 13485 Certification?

 

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  • Do you need ISO 13485?
  • Do you need ISO 13485 to conquer international markets with your medical device?
  • Are you looking for an ISO 13485 consultant to do it for you?
  • Are you a company that develops, manufactures, installs or provides service for a medical device?
  • Do your customers demand certification of compliance with regulatory requirements as a threshold condition for doing business with you?
  • Are you planning to market a medical device in the US or Europe and are you preparing to obtain the appropriate approvals?
  • Have you already developed a medical device and are seeking advice for ISO 13485 certification?

What is ISO 13485 and what is its purpose?

ISO 13485 is intended for organizations that develop, manufacture, install, distribute, or provide service for a medical device.

The standard details the quality management system requirements of medical device manufacturers in order to provide products that are safe to use and apply with the regulatory requirements of international bodies such as CE, FDA, TGA, etc. The standard is set by the International Organization for Standardization.

When marketing a medical device in the European Union, the product must comply with the requirements of the European Directives for medical devices and must bear the CE mark issued by Notified Bodies, which have been certified by the health authorities in the EU countries. In the product approval process, the manufacturer must prepare a technical file of the product and quality system to prove that the manufacturer and product do indeed meet the requirements for obtaining the CE mark.

In addition, when marketing a medical device in the United States, the product must meet the FDA requirements and be approved by the FDA. In the product approval process, the manufacturer must prepare a technical file of the product and quality system to prove that the manufacturer and product do indeed meet the requirements for obtaining FDA approval.

If the organization’s medical equipment quality management system complies with the requirements of ISO 13485, certification according to this standard means that the organization also complies with the requirements of ISO 9001.

Setting up a quality management system according to the requirements of ISO 13485 provides the organization with:

  • A proven and necessary basis for obtaining regulatory approvals enabling the supply/sale of products in global markets.
  • Control, evaluation and improvement of the organization’s processes throughout the product life cycle (from the beginning of development to the after-sale use of the device).
  • Full traceability of the materials and components of the medical device throughout the production process from the material level to the finished product level.
  • A mechanism for examining the effectiveness of use and the clinical performance of the medical device, and obtaining information that will enable the product to be improved in the future.

OK Consultants do this with you and for you:

  • Develop a quality management system for you that includes all the processes required by the regulatory bodies in the US and Europe;
  • Compile with you the technical file required for obtaining CE approval and meeting the stringent conditions in order to market products to EU countries;
  • Accompany you on the external audits and assist insofar as is necessary with the auditors;
  • Support the implementation of the processes at your organization until ISO 13485 certification is obtained;
  • Develop an integrative process that also meets the quality management requirements of ISO 9001 , as well as the requirements of ISO 13485 – all inclusive;
  • We teach you what to do so you can do it yourselves every year;
  • Or we do it for you annually at a reduced cost

Want us to do it for you?

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Frequently asked questions about the ISO 13485 certification process

What is it for me?

Setting up a quality management system according to the requirements of ISO 13485 …

  • Proves that the company adopts the necessary safety measures for medical devices in order to prevent harm to the customer and to maintain the safety of the medical device
  • Constitutes a proven and necessary basis for obtaining regulatory approvals enabling the supply/sale of products in global markets: CE in Europe, FDA in the United States.
  • Enables control, evaluation and improvement of the organization’s processes throughout the product life cycle (from the beginning of development to the after-sale use of the device).
  • Enables full traceability of the materials and components of the medical device throughout the production process from the material level to the finished product level.
  • Constitutes a mechanism for examining the effectiveness of use and the clinical performance of the medical device, and obtaining information that will enable the product to improve in the future.