How to ensure compliance with Quality Standards through Quality Engineering

Medical devices play a critical role in the diagnosis and treatment of ailments. They have become handy tools for physicians and surgeons to understand the nature of the ailment, the various parameters driving its prognosis, and the way to treat it. No wonder, their smooth functioning is of paramount importance to arrive at a correct diagnosis and follow the right treatment protocol. Also, modern-day medical devices are embedded with sensors and software that run various functionalities. The software within such devices collects vital parameters or data from patients, processes them in accordance with the laid-down protocols, and generates accurate outcomes.

If any of these stages contain bugs or glitches or a flawed methodology, the outcome may be erroneous thereby creating serious implications for the patients. Traditional medical device software testing may not be adequate to ensure top-notch quality for such devices. To ensure the embedded software and sensors work as expected and meet the desired quality and compliance standards like ISO 13485, ISO27001, and others, quality engineering for medical devices should be incorporated into the value chain.

Why medical device quality engineering?

Today, quality has assumed an overarching dimension touching areas like system architecture, information management, systems engineering, product management, and security management, among others. Ensuring medical devices software validation by pursuing the conventional waterfall method of manual testing where testing is done after development, does not embed quality throughout the SDLC. The need is to embrace medical device quality engineering to plan, embed, measure, and deliver quality at every step of the development process. The focus is on having enhanced collaboration among teams to get timely feedback on issues and ensure quality deliverables. Since medical devices ranging from imaging equipment and pacemakers to implants and artificial joints have a direct bearing on patients’ health, they should be designed according to the standards of quality compliance. In fact, such standards make sure the design or manufacturing process produces the desired quality consistently to help patients and healthcare professionals.

There are several challenges in designing and manufacturing medical devices. If adhering to regulatory requirements is one aspect of the whole process, incorporating advanced and evolving technologies like IoT, AI & ML, robotics, and augmented reality is another. Quality engineering for medical devices ensures such technologies and regulatory compliance are incorporated right from the design phase. Its impact can be felt in areas like connectivity, analytics, collaboration, usability, and scalability. With quality engineering in the medical devices testing approach, the presence of the above-mentioned technologies can lead to a transformation of quality culture, collaboration, and leadership.

Common medical device quality standards for Quality Engineering

Given the critical role of medical devices in the lives of patients, several compliance standards have been devised for every medical device manufacturer to comply with.

ISO 9001: Applicable across industries, this quality standard requires the medical device manufacturers to manage the quality control process, make organizational changes, improve accountability, reduce cost, and facilitate growth.

ISO 27001: Cybercrime has emerged as a strong threat vector wherein hackers can gain entry and manipulate the functioning of medical devices given the devices’ increased connectivity. It can also lead to risking valuable intellectual property rights through data breaches. Quality engineering can facilitate medical devices cybersecurity testing by using tools and industry-recognized best practices to assess and manage the inherent risks. ISO 27001 certified standard would mean the medical device manufacturers can adapt as per the perceived threats and maintain continuity to preclude such threats.

ISO 13485: Specially designed for the manufacturers of medical devices, this quality standard expands on ISO 9001 to harmonize the regulatory requirements. Adhering to ISO 13485 helps medical device manufacturers to ensure overall quality control, process validation, traceability, and risk management. Moreover, achieving the specific compliance standard through medical device performance testing can prepare the products for the international market. Regulatory compliance can streamline the manufacturing and testing processes and drive a more efficient, risk-averse, and profitable value chain.

In addition to the above, quality engineering pursued by medical device testing services can ensure the following:

Easy collaboration: A quality management process driven by QE can track and monitor every stakeholder associated with the manufacture of medical devices. Right from the vendor supplying raw materials to testers looking into the quality aspects can be tracked and notified should there be any non-conformance with the quality parameters. This can ensure everyone’s collaboration in taking corrective action without passing the buck.

Proactive identification of bugs: With more number of medical devices being made IoT-enabled, a QE-driven quality management process can monitor the generated data, identify non-conformance, and initiate positive responses.

Conclusion

Quality engineering comprising principles and processes to drive quality assurance and control can incorporate changes in the design and development phases. These can lead to the delivery of bug-free products given that every stakeholder in the development value chain would understand the business objectives and aim to realize them.

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James Daniel is a software Tech enthusiastic & works at Cigniti Technologies. I'm having a great understanding of today's software testing quality that yields strong results and always happy to create valuable content & share thoughts.

Article Source: medium.com

Michael works for Cigniti Technologies, which is the world's first Independent Software Testing Company to be appraised at CMMI-SVC Level 5, and an ISO 9001:2008 & ISO 27001:2013 certified organization.