Are you a medical device manufacturer looking to navigate the complex regulatory landscape in the UK?
ENSURE SMOOTH MARKET ENTRY WITH ASPHALIONʼS MEDTECH UK RESPONSIBLE PERSON SERVICES
Specializing in MHRA Compliance and Regulatory Affairs for Medical Device Manufacturers
As your UK Responsible Person Asphalion will not only act as your official representative with the MHRA, but will also provide you with comprehensive support to ensure compliance and successful market entry.
OUR MEDTECH UK SERVICES
- Responsiveness to any request and/or inspection from MHRA
- Support for the Registration of Medical Devices with the MHRA
- Regulatory Intelligence to monitor any change in local legislation
- Management of incidents and/or complaints
- Notification of incidents and/or complaints to MHRA
- Support for the UKCA approval for new and CE certified medical devices
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.
Quality
Memberships & Partnerships
