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Due to a growing and aging population, the demand for medical devices is ever-increasing. Globaldata predicts the medical devices market will reach a worth of $700bn by 2030, and as the industry grows, there is a huge demand for supply management across the value chains of quality products.
During or in the advancement of a Public Health Emergency (PHE), medical device manufacturers are obligated to inform the FDA of discontinuances or interruptions in the manufacture of a specific device that is likely to lead to disruption in the supply of the respective device in the United States, including those that are critical to public health during a PHE. Notice section 506J(a) of the FD&C Act.
This is where regulatory commissions such as the International Organization for Standardization (ISO) comes to the scene to guarantee that all medical devices meet the appropriate regulatory compliance laws, ISO developed ISO 13485, an internationally approved standard that determinates all the conditions for manufacturing, the related supply chain standards and the quality management systems (QMS) required for medical device manufacturing.
Seisa manufacturing and supply chain processes fasten new product development and provide better customer value. Seisa offers medical device manufacturers interventions that improve operational efficiency and deliver better value to customers.
With our industry-specific conditions, such as under the FDA and EU Medical Device Regulation (MDR), medical device manufacturers have several laws to comply with to achieve and maintain market permits.
Designing parts proactively, with the help of accurate data from deep in the supply chain and industry-top expertise, saves time and resources and keeps manufacturers ahead of threats.
Tracking and metrics, not only for our operations but also for our suppliers, keep our supply chain lean and reliable. We deliver advanced materials to the production lines in the right amount of time.
With a deep understanding of logistics in North America, Seisa Medical has become the perfect partner for manufacturing medical products at the U.S.-Mexico border and strategic locations on the East and West coasts of the US, constantly improving capabilities to meet the needs of the industry.
Disciplined administration of Key Performance Indicators (KPIs) assures early detection and prevention of any supply chain disruption. We observe lead time, availability, material obsolescence, prices, supply directions, and other variables to maximize supply chain benefit.
Seisa provides a customized solution for your project. We manage all the supply chain elements for optimization, including inbound and outbound logistics, vertical integration, supplier selection, and vendor management. Speak to a Specialist
For more information regarding our supply chain solutions for medical devices, feel free to contact Seisa.
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