Increased complexity in the Medical Devices regulatory landscape is generating greater challenges that need to be addressed in order to maintain a competitive position in the market.
Asphalion’s solutions for Medical Devices cover a full range of technological segments, such as: Implants, Wound-care, Wearables, IVDs, Software as Medical Device, Substance based and Drug Device Combinations, among others.
Starting from a proof of concept, throughout the design & development process, product approvals and maintenance of the device in the market, Asphalion can provide you with full Regulatory and Quality Management System (QMS) support for a time to market optimisation by minimising regulatory setbacks since the very beginning.
Increased complexity in the Medical Devices regulatory landscape is generating greater challenges that need to be addressed in order to maintain a competitive position in the market.
Asphalion’s solutions for Medical Devices cover a full range of technological segments, such as: Implants, Wound-care, Wearables, IVDs, Software as Medical Device, Substance based and Drug Device Combinations, among others.
Starting from a proof of concept, throughout the design & development process, product approvals and maintenance of the device in the market, Asphalion can provide you with full Regulatory and Quality Management System (QMS) support for a time to market optimisation by minimising regulatory setbacks since the very beginning.
Medical Devices Solutions
Our Medical Device services include:
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Why Asphalion?
With a strong track record of successfully executed projects for a wide range of products, including EU funded projects for development of highly complex and innovative technologies, Asphalion has gained key expertise in different technological areas and key regulatory areas.
In addition, Asphalion is strongly committed with digital transformation, which drives our team to provide expert support in development of digital solutions as medical devices. Furthermore, Asphalion is part of different MedTech clusters, which allows us to be at the forefront of digital innovation in the healthcare arena.
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