Which is the mandatory standard for the medical device industry?


Every day, medical devices support medical personnel in the fight for human health and life. Therefore, there is no doubt that it has to be reliable equipment that you can fully trust. That means that medical devices must function effectively without causing damage or any electromagnetic disturbance to their working environment. Therefore, medical devices must meet very demanding standards in order not only to meet legal standards but also to minimize any risks on the part of their users. So what criteria should medical devices meet? The ISO 13485 standard provides the answer to this.

From implantable life support devices, equipment for the detection and diagnosis of diseases and health problems to the most sophisticated diagnostic imaging equipment and minimally invasive surgical equipment, each of these items is a medical device (MD), and before it can be marketed and used in a working environment must first meet specific requirements. Therefore, OEMs who want to sell their products in the European Union and markets worldwide are looking for EMS service providers who meet the needs of the regulations. In addition, demanding products such as medical devices require structured systems, years of manufacturing experience, and attention to detail. Therefore, OEMs should pay special attention to EMS provider’s compliance with specific standards for manufacturing and import, export, processing, container, packaging, storage, and sale when selecting a contract electronics assembly supplier for medical devices.

Where can you find standards for medical devices?

Detailed criteria provided the norm ISO 13485 “Medical devices – Quality management systems – Requirements for regulatory purposes is an International Organization for Standardization,” which defines the requirements for a quality management system that can be used by organizations for the design and development, production, installation, and service of medical devices, and the design, development, and provision of related services. When it comes to launching medical devices, you cannot compromise on quality and accuracy. By working with a contractor who has an ISO 13485 certificate, you can be sure that you have established cooperation with a supplier of the highest quality solutions for the medical industry, thanks to which your products will be recognizable and trustworthy, and above all will effectively support saving the health and lives of patients around the world.

Standards and quality of medical electronics: ISO 13485

New legal regulations impose more and more difficult-to-meet requirements for medical devices at virtually every stage of a product’s life. Therefore, OEMs and their subcontractors must demonstrate the effectiveness of their quality management processes and implement best practices in all their activities. The ISO 13485 standard guarantees that.

ISO 13485 is a globally acknowledged norm for quality management methods in medical device production. It designates the conditions for a quality management system where a company must prove their capacity to provide medical equipment and associated services that consistently comply with customer specifications and applicable regulatory requirements. It is intended for organizations to develop, produce, install, service, and sell medical products. ISO 13485 is based on ISO 9001 but incorporates appropriate conditions for medical devices such as risk analysis, sterile manufacturing, and traceability.

Why is ISO 13485 so important?

On May 26, 2020, the transition period for the MDD / AAIMDD directives ended. New EU regulations concerning the production of medical devices MDR (Medical Devices Regulation) replace them. For the manufactured medical devices to be approved, it is necessary to meet the requirements of this directive and obtain the certificates required to introduce the products to the European Union market.

Under the new regulation, entities responsible for the design, development, and production of medical devices are obliged, among other things, to down:

  • Having quality management systems and risk management systems
  • Having systems that allow products to be assigned unique UDI identification codes
  • Preparation of technical documentation, application of conformity assessment procedures
  • Having systems in place for post-market surveillance

The ISO 13485 standard mainly includes these requirements. Therefore, having a valid ISO 13485 certificate by a manufacturer or service provider of contractual production of medical equipment means that it meets all the criteria defined in the new regulation.

ISO 13485 and choosing contract EMS providers

Electronics contract manufacturing vendors are critical partners for OEMs whose performance could compromise product compliance. EMSs must therefore provide manufacturers with evidence of compliance as to the quality of their services. That, of course, requires an appropriate quality system implemented by the subcontractor. Here, ISO 13485 will be extremely useful as it will allow OEMs to assess whether contract service providers will enable them to meet the stringent regulatory requirements. Furthermore, obtaining the ISO standard shows that the electronics assembly supplier provides quality systems through tested processes. Internally, ISO standards ensure focus and discipline, which means you can consider such a supplier trustworthy.

ISO 13485 certification is not enough

However, it is worth emphasizing that ISO 13485 is not a standard defining the quality of a medical product itself. It is a standard used to ensure a high-quality process, confirming that the end product meets the desired assumptions and thus complies with the required regulations. That is why selecting a contract service provider with a valid ISO 13485 certification enables the OEM to meet regulatory requirements. Having a certificate confirming that the process complies with the quality standard will not necessarily be enough.

ISO 13485 only indicates that the company follows a procedure recognized by an independent body that checks it regularly. However, certification is not mandatory when placing medical products on the market and guarantees quality or safety. Therefore, the mere use of a certificate does not mean that the electronics contract manufacturer will provide electronic products that meet regulatory requirements and meet the highest quality standards. Therefore, when deciding to entrust electronics production to an external contractor, it is also worth considering their years of experience, the repeatability of procedures within the organization, and the types of medical device inspections they offer.

There is no such thing as zero risks in medical procedures. At best, OEMs can minimize the risk, and one of the most critical conditions is selecting an experienced EMS provider who can be trusted and who, thanks to meeting standards and vast experience, will guarantee the highest quality of work.

For more information, visit https://asselems.com/en/medical-electronics-manufacturing