Navigate EU MedTech Regulations with Asphalion, your Trusted EU Authorised Representative (EU AR)
EXPERT SUPPORT IN COMPLIANCE WITH EU REGULATIONS FOR MEDICAL DEVICES AND IN VITRO DIAGNOSTICS
Looking for a trusted partner to help you comply with the European regulations for Medical Devices and IVD?
As your EU Authorised Representative (EUAR), Asphalion is committed to guiding you through every step of the process, ensuring efficient communication, confidentiality, full lifecycle support, and cost-effective solutions.
OUR EU AUTHORIZE REPRESENTATIVE SERVICES
- Contact point with EU Competent Authorities and Notified Bodies
- Keeping Technical Documentation and Declaration of conformity available upon Health Authorities request
- Support with Medical Device and IVDs registrations, as required
- Regulatory assistance: stay compliant during the post-market phase of the lifecycle
Asphalion MedTech
Your Bridge to Global MedTech Compliance
Recognizing the unique challenges and entry barriers in the medical device market, we have created a dedicated sub-brand: Asphalion MedTech.
With a highly professional dedicated team of specialists, we provide tailor-made solutions and personalized communications to meet the unique regulatory needs and expectations of medical device entrepreneurs and manufacturers.
Schedule now a free meeting with our experts!
Tell us about your project, challenges or doubts. We will be happy to assist you!
Why Asphalion?
ASPHALION offers expert consulting, strategic advice, operational support and full outsourcing services for all drug development stages
Asphalion was founded in 2000 with the vision of offering high-quality services for the development,registration and manufacturing of innovative medications and medical devices.
Our passion and mission is to work together with our clients to generate ideas and implement solutions that contribute to improving health globally.
Our commitment to quality, flexibility, and customer satisfaction is what sets us apart.
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