Maintaining product quality and reliability is essential in manufacturing medical devices. An especially important topic is verification and validation (V&V)—the pivotal processes in the development and manufacturing of medical electrodes, which ensure product performance, regulatory compliance, risk mitigation, and, ultimately, customer satisfaction.
At Screentec, V&V is not just a checkbox in the development process – it is a commitment to delivering safe, effective, and reliable products to the healthcare market.
Understanding V&V: building a foundation for quality
Verification and Validation (V&V) is a critical process in developing and manufacturing medical devices. It involves two distinct but complementary activities:
Verification ensures that the product is being built correctly, confirming that it meets the specified requirements and operates within its intended environment.
Validation, conversely, ensures that the right product is being built, confirming that it fulfills the user’s needs and intended use.
V&V is a fundamental practice that lays the groundwork for high-quality products.
‘V&V ensures that the manufacturing process is built on robust practices from the early stages of product development’, said Jani Sutinen, Process Engineer at Screentec.
At Screentec, the V&V process is instrumental in meeting desired quality standards and exceeding customer expectations.
‘V&V helps verify and validate manufacturing process correctness, completeness, and reliability. By rigorously examining every aspect of the manufacturing process, we ensure that the products meet industry standards’, highlighted Hamza Khallok, Process Quality Engineer at Screentec.
Mitigating risks and enhancing reliability
One of the most significant advantages of V&V is its ability to identify and mitigate potential risks early in the development process. As Jani explains, ‘Potential manufacturing risks can be early identified through V&V, allowing for mitigation strategies to be implemented.’ This proactive approach not only minimizes the likelihood of failures or errors, but also contributes to reducing overall development costs.
When it comes to manufacturing medical electrodes, stability and reliability are non-negotiable.
‘V&V helps improve the reliability and stability of the manufacturing process, eliminating unexpected failures during production. Executing V&V requires a meticulous approach, starting with designing the manufacturing process in detail with all required tools and manufacturing equipment based on customer specifications’, added Khallok.
‘By subjecting every manufacturing process step to rigorous engineering tests, we ensure optimal conditions for repeatability and reproducibility,’ he continued.
Execution of V&V at Screentec
At Screentec, a master validation plan defines what processes and tools need validation or verification. ‘This plan is meticulously executed, with every validation or verification protocol reviewed by a validation team prior to execution’, Sutinen explained. The outcome? An approved validation or verification results pave the way for official use in production.
In the complex world of medical device manufacturing, achieving success boils down to innovation and playing by the rules. At Screentec, a recent milestone underscores their dedication to both, as the company successfully passed the audit by a key FDA-regulated client, affirming their status as a trusted manufacturer of their product. This achievement echoes their commitment to upholding quality and regulatory compliance.
Strategic importance of comprehensive V&V processes
Screentec’s comprehensive V&V processes enable seamless compliance with FDA regulations, facilitating smoother market approval processes and accelerating commercialization. With regulatory requirements becoming increasingly stringent, ensuring compliance is paramount for success in the US market and beyond.
‘Investing in V&V may seem like an added expense, but it is a strategic investment in long-term success. By addressing issues early in the development process, we can avoid costly redesigns, recalls, and regulatory delays, ultimately maximizing our clients’ return on investment. Our efficient V&V processes streamline the path to market, minimizing time and expenses’, concluded Sutinen and Khallok.
Source: Screentec