CONSULTANCY AND CERTIFICATION
ISO 13485 is the international standard determining the special requirements for the companies, operate in the medical device manufacturing industry (diagnostic and therapeutic products).
The ISO 13485 Certificate ensures the continuity of the ability to determine and meet the customer demands for each company operating in the operational processes such as production, sale and procurement of medical devices.
It ensure the customer confidence on the fact that the products are manufactured in a system that is safe for human health in all phases such as beginning from raw materials to design, production, storing and shipment.
The ISO 13485 Certificate is required for manufacturers of medical devices to meet the legal requirements and to obtain CE Mark.
Why is ISO 13485 a good idea for your organization?
The benefits of ISO 13485 cannot be overstated. Companies of all sizes have realized significant savings in cost and time, plus other improvements that an efficient Quality Management System naturally bring about. The following is a list of six top reasons to implement ISO 13485 in your company:
ISO 13485 is the internally recognized gold standard for quality in the medical device industry. Certification to this standard shows clients and customers that your company takes quality very seriously, and that you have a system in place to ensure it. Your QMS can be a powerful marketing tool, and it has become a requirement in many countries for suppliers to show compliance. This translates to more opportunity.
