Sertifikasi ISO 13485 – ISO 13485 is an international standard for the design, manufacture and distribution of medical devices. ISO 13485:2012 is the latest version by ISO, published in 24th July 2003. This standard is based on the ISO 9001:2008 process model approach.

Benefits of Implementing ISO13485 standards:
The main internal benefits of 13485 standard is that it indicate a preventive approach to assuring medical device quality which the process inspection and rejection are done at the end of the manufacturing line.

• Its provides a systematic framework for to define, implement, measure and analyze the process of business operation and customer opinion.
• It provides a systematic framework on monitored base that resulting in less waste and fewer complaints.
• Reduction of operating costs, reduction of nonconforming products costs, raw materials, energy and other resources saving.
• This standard focused to improve the performance in areas such as sales, product delivery, and process efficiency.
• Its reduce costs as a result of minimizing product failures.
• Through ISO 13485 standard organization access to the competitive edge with our independently.