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:
The PRRC, or Person Responsible for Regulatory Compliance, is a new role introduced by the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The PRRC is responsible for ensuring that a medical device manufacturer complies with all applicable EU regulations. This includes ensuring that the manufacturer’s quality management system (QMS) is compliant, that the devices are designed and manufactured safely, and that they are properly marketed and post-market surveillance.
The PRRC must have the following qualifications:
The PRRC’s responsibilities include:
The PRRC can be an employee of the manufacturer or a third-party consultant. If the PRRC is a third-party consultant, the manufacturer must enter into a contract with the consultant that specifies the consultant’s responsibilities and liabilities.
The PRRC is an important new role under the EU MDR and IVDR. By ensuring that manufacturers comply with all applicable regulations, the PRRC helps to protect patients and ensure the safety of medical devices on the EU market.
If you are a medical device manufacturer, you need to ensure that you have a qualified PRRC in place. If you do not have the in-house resources to provide this function, you can outsource the PRRC service to a qualified consultancy firm.
At Asphalion we can help you with your PRRC needs. We have a team of experienced regulatory experts who can provide you with the support you need to comply with the EU MDR and IVDR. We can help you with all aspects of the PRRC process, from qualification and appointment to day-to-day support. We can also help you with other regulatory affairs matters, such as product registration, documentation preparation, and audit support.
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?
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.
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.
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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.
Main benefits
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