By accompanying you
We support you.
INDIVIDUAL - PARTNERSHIP - EFFICIENT
We as Team MEDAGENT see ourselves as your partner in the areas of quality management, regulatory requirements, process and software validation as well as quality testing and logistics processes. With our subsidiaries in Germany, USA and Brazil we offer you qualified contacts and expertise in interesting medical device markets.
We accompany our customers with enthusiasm from the idea to the first time the products are put on the market and are also available with advice and support during the entire product life cycle.
How do we make your process?
Seminars, workshops or full support in daily business?
For us, your needs are our priority – whether you are a two-man start-up or an established company with more than 1,000 employees.
We design, support or optimize your processes and ideas with our knowledge, experiences and competences.
In times of increasing digitalization, omnipresent social media and industry 4.0, we are always available for you via various communication channels.
With us through the Audit...
...IN THE USA
To harmonize the respective laws, approval tests and documentation in Australia, Brazil, Canada, Japan and the USA the Medical Device Single Audit Program (MDSAP) was introduced.
Do you want to approve products outside of Europe, the USA or Brazil? We advise and support you in implementing the requirements of the MDSAP and accompany you through the audit of an accredited Notified Body.
In order to be able to place a medical device on the European market, the manufacturer must undergo a conformity assessment procedure. This procedure confirms that
- the manufacturer meets the organizational requirements to be allowed to place medical devices on the market
- the manufactured medical devices meet the essential safety and performance requirements and therefore the CE marking may be affixed
The FDA (Food and Drug Administration) is responsible for the approval and market surveillance of medical devices in the USA.
We will gladly support you in the following activities:
- Registration of your company (Establishment Registration)
- Registration of products (Medical Device Listing)
- Approval of medical devices (510(k) Premarket Notifications, De-Novo Applications, PMA (Premarket Approvals))
- Preparation and successful execution of FDA inspections
With our representative Service
to the international approval
Are you looking for a trustworthy partner to bring your products to the market with the greatest possible flexibility, but do not have the necessary network or knowledge of regulatory requirements for market approval?
Then we are the right contact for you! – Through our branches and representative services we take care of the approval process and act as your correspondent with the national authorities.
QUality & Logistic Hub
NO MORE OVERCROWDED WAREHOUSES
Your core competence lies in sales and marketing of medical devices?
You do not have the necessary resources to implement all required quality assurance measures and/or your company is located outside the European Union and need an EU authorized representative?
– We can provide you with space!
With our quality and logistics hub we support you in quality assurance and ensure a smooth transport chain.