The business world is shrinking through collaboration, innovation, and communication. At DQS, we adapt to be effective with a "Local at Heart and Global by Spirit" mindset.
Medical devices in the healthcare system must be safe and effective, certified by Notified Bodies. Compliance with regulations, legislation, and international standards is expected for medical devices. Supply and demand challenges for the medical device industry and Notified Body services have increased after the introduction of theMedical Device Regulations (MDR), replacing the EU MDD (Medical Device Directives). This article showcases how DQS, as a Notified Body, brings an innovative approach and deep understanding to support the medical device industry with a "Local at Heart and Global by Spirit" mindset.
Core of the Business Challenge and its impact:
Medical device manufacturers must obtain CE marking certification for MDR to enter the European market. This involves assessing the device's technical file and auditing the medical quality management system. Healthcare professionals and patients rely on certified devices to ensure safety and efficacy. Furthermore, new devices are being developed to enhance effectiveness and safety through advancements in materials and technology.
As the population grows, the demand for such devices increases. However, there is a shortage of available Notified Body services due to stricter regulatory requirements. The widening gap between supply and demand poses a significant challenge. If a device lacks certification, it cannot be marketed or used. Delayed certification prolongs the time it takes for manufacturers to bring their products to market, causing patients to wait longer.
Service Innovation model from DQS:
DQS has implemented a hub and spoke model to address this challenge. The process has started, establishing competence centers in India, the US, and Japan, while maintaining the headquarters of the Notified Body in Germany as a Center of Excellence (CoE). These competence centers will cater to local needs and offer global support, focusing on device-specific expertise requirements. Both the competence of assessors and process maturity play crucial roles, with industry experts handling back-end processes, customer service, and regulatory affairs.
We are further expanding this model in emerging markets such as the UK, Asia, and Australia to significantly reduce our turnaround time (TAT). This means that shorter waiting times for assessments will result in quicker availability of certified medical devices on the market, enabling patients to receive the safe and effective medical devices they need more promptly.
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