A successful implementation will demonstrate a company’s ability to supply medical devices and related services to customers that comply with regulatory requirements. ISO 13485 is not just product focused, but it focuses instead on the processes used to develop medical devices. Keep in mind that you also need to comply with all relevant products and service oriented technical standards and regulations in this area of expertise.
ISO 13485 QMS for Medical Device
Benefits
- Is recognized globally as the best quality practices from organizations within the medical device industry.
- Enables you to work within many countries where it is a regulatory requirement such as CE Mark in Europe and with many organizations where it is a contractual obligation or expectation.
- Helps create a systematic framework in which organizations monitor, measure and analyze their processes and customer feedback.
- Helps provide a framework for implementation of actions (where necessary) to ensure achievement of planned results and to ensure maintenance of effectiveness of those processes with applicable customer, quality and regulatory requirements.
- Can provide improved performance measurable in key metric areas such as increased sales, increased timeliness in getting products to the global marketplace, reduced costs , fewer errors, less waste, better use of time and resources and lower product failures.