ISO 13485:2016

We have been independently assessed by NQA against internationally recognized standards showing our commitment to quality and assurance.

We have been certified to ISO 13485:2016 the International Quality Management Systems for Medical Devices.

According to the standard, ISO 13485:2016 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are applicable for their intended purpose.

As outlined, and as widely understood, there are multiple benefits of ISO 13485:2016 certification. With it, an organization can increase access to more markets worldwide, improve processes across the organization, increase efficiency, cut costs and effectively monitor supply chain performance.

Winco’s goal is to manufacture compliant and safe medical devices meeting regulatory requirements and exceeding customer expectations, achieving and maintaining this certification is our means to insure this goal is met.

This certification is a part of our commitment to provide our customers with the ongoing level of excellence that they have come to know from Winco and TransMotion.

ISO13485 Certification