A quality system rigorous enough to support the critical needs of the medical device industry is a necessary component of any supplier or processor doing business in that sector. But exactly what does that include? The short answer is a little bit of everything.

Quality procedures and documentation—from IQ/OQ/PC (installation qualification/operational qualification/performance qualification) to adherence to ISO 13485 quality management standards, to compliance with FDA good manufacturing practices—must pervade throughout the entire organization.

Ensuring that processes meet necessary quality standards is relatively simple when device firms work with suppliers and processors that have robust engineering resources.  Firms with capabilities from prototype to production and FDA submission can offer device makers help in selecting materials and parts design to improve functionality while ensuring a stable manufacturing process.

Defining IQ/OQ/PQ

IQ/OQ/PQ is a complete verification of equipment and process protocol often required by medical device companies, and performed by each supplier. One particularly rigorous method of documenting the production process is known as “alphabet soup.” With this method, everything that happens to a component gets documented—for example, which machine it will be run on, what inspections will be conducted, and at what frequency, etc. To ensure that the process is sound, the documentation may also include a capability study and gauge repeatability and reproducibility to prove out any variances in setup and operator factors.

Each IQ/OQ/PQ should be conducted to suit the requirements of the customer, and the process must be adjusted as needed to match hardware functionality. For example, a validation procedure may demonstrate that the development meets engineering requirements and acceptance criteria for nominal settings on a sample set of components. A statistical analysis must be carried out for each process step.

After the detailed work is completed, to ensure regulatory compliance it is essential that the supplier prepare and maintain the applicable machinery and equipment qualification reports for auditing purposes. No structural changes may be made to the equipment without first notifying the customer and evaluating whether a requalification is necessary.

ISO 13485 certification

An important aspect of the medical device quality support story is the ISO 13485 medical device standard, “Quality management systems—Requirements for regulatory purposes,”  which outlines a comprehensive quality management system for the design and manufacture of medical devices. Subcontract manufacturers that achieve this certification can demonstrate that they are processing parts to the same rigorous standards as are major medical device manufacturers.

ISO 13485 involves the development of controls to ensure product safety with a focus on risk management and design control activities during product development. For implantable devices, there are specific inspection and traceability requirements; sterile medical devices require verification that corrective and preventive actions will actually be effective.

To gain the certification, the service provider generally conducts an internal quality audit to ensure that it meets the standards, and then contracts with a third party for the actual registration audit. The company then trains its own internal quality auditors who work to maintain the standards. 

Joining Technologies decided to pursue ISO 13485 certification as a way of showing that it processes parts to the same standards as its medical customers. The company was already certified to quality management standards under NADCAP (National Aerospace and Defense Contractors Accreditation Program) and AS9100, so the move to ISO 13485 was a natural step.

FDA requirements

According to the FDA’s Quality System (QS) Regulation/Medical Device Good Manufacturing Practices, “Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.” Quality systems for FDA-regulated medical devices are known as current good manufacturing practices (CGMPs). Over the years, CGMPs for medical devices have been revised to include design controls, becoming more closely aligned with the international standards found in ISO 9001 and ISO 13485.

In 1997, FDA revised the CGMP requirements for medical devices and incorporated them into a quality system (QS) regulation called “Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation,” found in 21 CFR Parts 808, 812, and 820. While not regulating exactly how a manufacturer should produce specific devices, the QS regulation sets out a framework to be followed, requiring  manufacturers to use “good judgment” when developing their quality system and applying the QS sections that are specific to their products and operations.

From prototyping through FDA submission

While there are many details involved with developing and implementing a quality process, it all comes back to these factors: device developers need to work with suppliers and processors with robust engineering resources, and the engineering teams must be involved from prototype to production and FDA submission. This allows development engineers to provide input on functionality and, if necessary, the redesign of parts.

When these factors are in place, the likelihood that quality processes will be, too, are greatly enhanced

Developing and implementing a quality welding process


Quality systems for the welding of medical devices rely on a variety of standards. A project is most likely to succeed when a medical device manufacturer works with an engineering firm that performs feasibility studies, process development, validation and certification, systems engineering and integration, and full-scale production. Such engineering firms enable device developers to see how their parts get welded and they remain involved throughout the qualification and productions stages, while adhering to a strong intellectual property (IP) program that ensures protection of the customer’s IP.

Maintaining a flexible approach in the joining process, including the ability to access a variety of fusion techniques, helps provide optimal solutions based on part design and geometry. Companies offering electron beam, laser, and traditional welding techniques within the same facility have a clear advantage over those that are limited to, for example, to just laser welding.