Various medical devices are used in different fields, such as diagnostics, minimally or non-invasive surgery, 24-hour patient monitoring, remote monitoring, clinical research, and more. Therefore, all biomedical devices require specific standards and regulations. Here are some standards and regulations that every PCBA manufacturer should be aware of:

IPC Standards
Formerly known as the Printed Circuit Association (hence the acronym IPC), now known as the Connected Electronics Association. It is an international industry association responsible for publishing a series of circuit board standards. Some important criteria are as follows:

IPC-A-600: This standard covers the acceptability of circuit boards.
 IPC-A-6012: It covers the qualification and performance specification of PCBs.
 IPC-A-610F: It also covers the acceptability of electronic assemblies. There are different IPC standards for harnesses, welds, enclosures, and cables.

ISO 9000 
ISO stands for International Organization for Standardization. Along with the 9000 series, it publishes several standards covering reliability and quality requirements for circuit board design, manufacturing, and testing. OEMs should be certified to one of the ISO 9000 basic safety and essential performance standards for medical devices.

FDA
The US Food and Drug Administration introduced 21CFR820, a quality system regulation. The standard requires medical device OEMs to perform manufacturing and quality control processes without validating subsequent tests or inspections. The regulatory agency confirms that the product meets certain requirements if the OEM has the relevant approvals and certifications.

ISO 13485 
It is an important standard for PCB and PCBA manufacturers as it determines the quality management system for equipment in the medical industry. This standard aligns with the ISO 9000 series to specify quality and reliability requirements for medical products. ISO 13485 defines specific standards for circuit board manufacturers to establish a documentation process to track all materials and components used in manufacturing. This is critical for manufacturers of medical devices to understand the recall process for materials and components.

Not all standards require OEMs to be certified to develop medical products. However, these standards and regulations show customers that manufacturers have invested in the necessary systems and are fully focused on PCB assembly guidelines to meet all requirements.