ISO 13485: 2003 is a standard that sets out the steps required to implement a medical device management system. It concerns companies that design and produce medical devices, that market medical devices, that install and provide technical support for medical devices.

The implementation of ISO 13485 is a requirement of the legislation (National legislation, Ministry Decision 1348/2004 / Government Gazette 32B ').

The ISO 13485 standard is based on ISO 9001 but gives special emphasis to all those parameters that ensure the safety of medical devices.

Organizations that must seek their certification according to ISO 13485: 2003 are:

• Medical devices industries
• Medical technology marketing companies

HELLASCHEM ensures the provision of the highest quality consulting work for the preparation, implementation and certification of the organization according to ISO 22716, thanks to:

• To its well-trained staff
• In the ongoing engagement with legislation, health and safety and cosmetic technology
• The possibility of proper control of supplier documents, laboratory results, etc.
• Optimal time management for the proper implementation of the food safety system, so that the minimum employment is required for the implementation of ISO 22716 by the staff.

HELLASCHEM provides:

• Consulting service for the development, implementation and certification of an organization according to ISO 13485: 2003
• Internal inspections to verify the correct application of ISO 13485: 2003
• Inspections at supplier facilities
• Staff training on safe cosmetics production
• Maintenance and extension of an existing ISO 13485: 2003 system
• Combined application of ISO 13485 with other standards such as ISO 9001, ISO 14001, ISO 45001
• • Laboratory analyzes for the control of raw materials, medical devices, as well as for the control of the hygiene of facilities and employees