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ISO 13485:2016 Certified Quality Management Systems - Medical Devices

ISO 13485:2016 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. 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 safe for their intended purpose. ISO 13485:2016 requires that consistent quality standards be met and maintained.

ISO 13485:2016 Conversation

ISO 13485:2016 Conversation with CEO Jon Crofford

Video Length: 2:11

What does ISO 13485:2016 mean for your Medical products?

Product Requirements: Ensures the design team and production team have a clear understanding of the end customer's expectations and product requred functionality. This helps the design and production team prevent common errors that can arise during production.

Reduced Liability:  Litigation from failed medical equipment can be expensive. Medical OEM's can benefit from the traceability, design, and materials validation, risks assessments, and other processes implemented by an ISO 13485:2016 contract manufacturer. 

Working with an ISO 13485:2016 contract manufacturer shows regulators and customers that your device was manufactured by an organization with a compliant QMS, ultimately improving your chances of passing the rigorous quality and safety requirements specified in FDA regulations.

Medical Assemblies

What does ISO 13485:2016 mean for your Non-Medical products?

The standards outlined by ISO 13485:2016 create a culture dedicated to quality and efficiency within an organization. Cost savings can be achieved through the identification of product or service deficiencies and the formulation of improvements. The end result is less waste or rejected work, fewer complaints, and more consistently met and on time orders. By partnering, this efficiency and cost saving gets passed on from the Contract Manufacturer to the OEM, creating more opportunities in the marketplace.

TLC Electronics looks forward to applying this new quality standard to your project. Whether you use our degreed engineers for design assistance or our skilled production team, consistent quality will be met and maintained throughout the project.

Any questions contact our customer service today.  customerservice@tlcelectronics.com or 1-833-207-0931


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