Manufacturing electronic devices for healthcare purposes is one of the most demanding industries. Original equipment manufacturers (OEM) have to ensure their goods are safe for customers and can actually contribute to their health. Meanwhile, they have to be able to prove it to regulatory institutions to get approval for launching the product.
Collaboration with a company holding an ISO 13485 certificate can make it significantly easier for you to enter the market.
Meeting exact product requirements
Outsourcing electronic manufacturing to a company that has acquired an ISO 13485 certificate can guarantee your service provider understands the required functionality of a medical device and knows which procedures to implement to assemble the device free from errors. Such a company also provides its personnel with extensive training on manufacturing procedures.
Long-time players in the space of electronics manufacturing, such as Polish-based Assel, also co-operate with trustworthy component and material vendors, which helps their clients to achieve a reproducible level of quality.
Traceability, transparency and efficient quality control
Many countries expect a medical device to have a traceable and transparent life cycle, otherwise, they will not allow it to reach the market. It is crucial for defining the sources of any possible problems that might occur in such equipment. In addition to it, the quality and risk control system should make it easy for manufacturers to monitor the products introduced to customers and collect their feedback.
If your electronics manufacturing service (EMS) provider has an ISO 13485 certificate, you can rest assured the entire production process of your device and its components will be traceable.
Compliance with governmental regulations
All the advantages mentioned above significantly contribute to the product quality and, therefore, increase customer satisfaction. It translates into higher income, which is key for any OEM.
Yet, the mere ability to launch a product is even more crucial. Providing excellent quality is not enough if you cannot prove it to regulatory institutions with a formally documented quality management system.
ISO 13485 remains the major certification proving alignment with the EU regulations for medical device manufacturing and providing services using these devices. Its recent updates increased its usability covering the requirements of The United States Food and Drug Administration (FDA). Furthermore, there are many other countries respecting this certification, for example, Australia, Canada, Brazil, Korea and Japan.
Conclusions
Regardless of the scope of work you decide to hand over to your EMS provider, complying with governmental regulations for electronic medical devices will be much easier if this manufacturer also holds an ISO 13485 certificate. To learn more about the offer for medical device production of an ISO 13485-certified manufacturer, go to asselems.com.
