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.
MedTech Solutions
Our Medical Device services include:
UK Responsible Person
As your UK Responsible Person we will not only assume the representative role with MHRA on your behalf, but also will provide you with:
With high knowledge and understanding of the EU and UK regulations and hence, their differences and synergies, we will assist you on establishing the best regulatory strategy considering the unique challenges and opportunities of the UK market.
US Agent
The FDA requires that all foreign manufacturers have a US Agent to act as their official representative in the United States. At Asphalion, we offer comprehensive US Agent services for medical device manufacturers looking to expand their business in the US market.
As your US Agent, we provide:
Our team of regulatory affairs experts has extensive experience working with medical device manufacturers and navigating the complex regulatory landscape in the US. We are committed to providing our clients with the highest level of service and support to ensure compliance with all relevant regulations and requirements.
As your trusted partner and EU Authorised Representative Asphalion will guide you to comply with European regulations for Medical Devices and IVD:
Why work with Asphalion?
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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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Quality Management System
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