In the fast-paced world of medical device manufacturing, maintaining product quality and reliability is essential. In this article, we explore the topic of Verification and Validation (V&V) – the pivotal processes in the development and manufacturing of medical electrodes, ensuring product performance, regulatory compliance, risk mitigation, and ultimately, customer satisfaction.
But what exactly is V&V, and why is it crucial in the development lifecycle? With insights from Screentec’s Process Quality Engineer Hamza Khallok and Process Engineer Jani Sutinen, we delve into the significance of V&V in meeting quality standards, mitigating risks, and enhancing reliability. 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 the development and manufacturing of medical devices, involving two distinct but complementary activities: Verification ensures that the product is being built correctly, confirming that it meets the specified requirements and operates as intended within its intended environment. Validation, on the other hand, ensures that the right product is being built, confirming that it fulfills the user’s needs and intended use.
In essence, V&V is a fundamental practice that lays the groundwork for high-quality products. As Jani Sutinen aptly puts it, “V&V ensures that the manufacturing process is built on robust practices from the early stages of product development.”
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 carefully examining every aspect of the manufacturing process, we ensure that the products meet industry standards”, Hamza highlights.
Mitigating Risks and Enhancing Reliability
Hamza (on the left) and Jani ensuring excellence at every stage of the manufacturing process
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 of 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”, Hamza elaborates.
This detailed analysis and mitigation of potential risks lay the groundwork for a robust V&V process. “By subjecting every manufacturing process step to rigorous engineering tests, we ensure optimal conditions for repeatability and reproducibility”, Hamza adds.
Execution of V&V at Screentec
At Screentec, a master validation plan is established to define what processes and tools need validation or verification. “This plan is thoroughly executed, with every validation or verification protocol reviewed by the validation team prior to execution”, Jani explains.
The outcome? An approved validation or verification results, paving the way for official use in production.
Screentec reached a significant milestone recently as we successfully passed the audit by our key FDA-regulated client, affirming our status as a trusted manufacturer of their product. This achievement echoes our commitment to upholding quality and regulatory compliance.
FDA serves as the regulatory authority responsible for ensuring the safety and efficacy of medical devices sold in the United States. Before a medical device can be marketed and sold in the US, it must undergo a rigorous approval process or conform to specific regulatory pathways established by the FDA. “This includes evaluation and approval of the product’s manufacturing process, commonly referred to as V&V”, Hamza points out.
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 both time and expenses”, Jani and Hamza conclude.
Looking for a partner to elevate your medical device manufacturing? Contact us to learn how our expert team can ensure quality and compliance every step of the way.
