An old saying goes, “Everyone has a boss, and the business owner’s boss is the customer.” It’s a good perspective to keep in mind. And for PCBA and electronics producers and service providers, standards and guidelines help ensure that CEOs and owners do not lose sight of this frame of reference—especially in the well-regulated medical devices industry.

Manufacturers often utilize process review, performed by an external evaluator or—in some cases—the company itself, to verify compliance with industry rules and guidelines. In either case, adequate documentation that meets the traceability requirements for medical devices is essential for an accurate assessment. And in a highly regulated industry, your CM must be a committed partner to help you satisfy this essential quality management activity.

What Is Traceability and Why Is it Important?

The ability to trace your steps is an invaluable asset, as it allows you to examine previous practices with foreknowledge of the outcome. However, this hindsight is only useful if it includes data or information that identifies actions or areas for improvement. For building circuit boards and electronics, traceability can be defined as follows:

Definition: Traceability for PCBA development refers to the ability to follow and document raw materials and components and the equipment and processes (including inspection and validation techniques) that utilize them throughout the manufacturing process via specific data such as product serial numbers.

When considering the importance of traceability for PCBA and electronics development in the medical industry, three primary attributes stand out.

Quality Management

For medical device OEMS and suppliers, the ISO 13485 standard establishes internationally agreed-upon requirements for virtually all entities involved in the lifecycle of a medical device. Direct suppliers to companies and organizations that utilize medical devices must adhere to this standard, including its documentation and traceability provisions. Other links in the supply chain that supply materials, components, services and maintenance may or may not be required by the OEM to meet the provisions of this standard.

Process Agility

PCB traceability requirements for medical device development enables manufacturers to develop and implement an effective risk management plan. ISO 14971—also an accepted international standard—provides a comprehensive framework for managing risk that includes multiple templates, such as Preliminary Hazard Analysis (PHA), Hazard and Operability Study (HAZOP) and Failure Mode and Effects Analysis (FMEA). Adopting one of these strategies is critical for ensuring the process agility that allows you to perform the quick changes that will improve the overall reliability of your product development process.

Legal Responsibility

A third reason for meeting PCB traceability requirements for medical devices is to establish legal protection in the event of a contingency with consequences that may include harm to a patient or other substantial damages. The ability to demonstrate your compliance with industry standards can be invaluable in such circumstances.

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As discussed above, there are several benefits to tracing your PCBA development throughout the supply chain. However, doing so effectively requires that all process participants establish protocols for accurate documentation collection and availability.

Meeting Your PCB Traceability Requirements for Medical Devices

• Follow the applicable industry standards

Electronic medical device standards.

• Create as agreed upon by user and supplier (AABUS) traceability requirements with your suppliers

Details on how to set up an AABUS traceability regimen. 

• Only work with a certified CM

Important medical device manufacturing certifications.  

As the list above indicates, ensuring that your traceability requirements are satisfied necessitates that you clearly communicate requirements to all development participants and ensure participants are committed to adhering to them.