"We are a home for quality and regulation" in all processes in the medical equipment industry:

  1. Authorization for ISO 13485 standard
  2. Approval from the Ministry of Health - AMAR registration (medical equipment)
  3. Business license to manufacture / import medical equipment
  4. European approval - CE
  5. Storage of medical equipment
תקן ISO 13485
What is the ISO 13485 standard?

ISO 13485 is a special standard for the medical equipment field, which includes specific additions to the ISO 9001 standard. The standard specifies the quality management system requirements for medical equipment manufacturers, in order to provide safe products for use, and in accordance with the regulation requirements of international bodies (CE, FDA, TGA, etc.). The standard is set by the International Organization for Standardization and is reviewed and updated every few years. The most recent version is from 2016.

למי מתאים תקן ISO 13485
Who is the ISO 13485 standard suitable for?

The ISO 13485 standard is suitable for organizations in the medical equipment field regardless of their size or specific area of ​​activity. Organizations eligible for the standard development opportunities for themselves worldwide, as it is a mandatory standard that helps meet regulatory requirements in many countries. In addition, many companies require the 2016 ISO 13485 standard as a threshold condition for transactions in the medical equipment field.

How to get ISO 13485 standard?

The standard is systematically embedded in organizations in order to meet regulatory requirements and the global market requirements for medical equipment. Our support at Sync Projects will assist the organization throughout the entire process. These are the main steps to obtain authorization for the ISO 13485 standard:

  1. Gap analysis. Our experts at Sync Projects will assess the organization's current situation and identify gaps that need to be addressed.
  2. Development and implementation of a quality management system (QMS). The organization will need to develop and implement a QMS in accordance with the ISO 13485 standard requirements.
  3. Internal audit. The organization will need to conduct an internal audit to ensure compliance with the QMS.
  4. Certification audit. An accredited certification body will conduct an audit to determine if the organization meets the ISO 13485 standard requirements.
  5. Continual improvement. The organization will need to continually monitor and improve its QMS to maintain compliance with the standard.

Obtaining the ISO 13485 standard assures your organization a significant first step towards regulatory and licensing processes in many countries around the world. It designates you as a quality mark holder in front of potential customers in the medical equipment industry.