Accelerating Medical Device Approval and Market Access with Confidence
Cost-Effective Support
Achieve an excellent return on investment with a dedicated team of regulatory experts managing the complexities of approval. We reduce the time, cost, and effort needed to build in-house expertise, helping you bring products to market more efficiently and with less risk.
Reliable and trusted Support
With over 25 years of experience, we provide end-to-end regulatory support for medical devices, guiding products from concept to market launch and throughout their lifecycle. Clients trust us to navigate the entire regulatory process and bring their devices to market successfully.
German Efficency
German Efficiency meets cutting edge tools within the Medical Device Regulatory support. Our clear processes and procedures ensure clients receive approvals quickly and mean they are always a step ahead of any changes in regulation.
Digital Hub
Clear, friendly communication with the MEDAGENT team, supported by well-organised documents in one centralised digital hub. Stop wasting time searching for files—everything is easy to find, with all documents for multiple global markets stored in a single, organised location.
UK Responsible Person
Brazil Registration Support
U.S. Agent Services
TGA Australian Sponsor
EU Authorized Representative
Quality & Regulatory Compliance
International Market Access
GDPR & Data Protection
MEDAGENT FUTURA
MEDAGENT Comply
Your Global Partner for Medical Device Success – From Idea to Approval.
Your Global Partner for Medical Device Success – From Idea to Approval.
MEDAGENT is your strategic partner for quality management, regulatory compliance, process and software validation, and quality assurance in the medical device industry.
With our headquarters in Germany, and other offices across the United States, Brazil, the United Kingdom, and Australia, we combine global reach with local expertise. Our highly qualified specialists support manufacturers in navigating complex international regulatory requirements and bringing innovative medical devices to market efficiently and compliantly.
From the initial concept and product development through regulatory approval and market launch, we provide comprehensive support throughout the entire product lifecycle. Our commitment is to help you achieve sustainable market success through streamlined processes, regulatory excellence, and uncompromising quality.
Why manufacturers & distributors of medical devices & IVDs worldwide rely on MEDAGENT
Experience and Expertise
With over 25 years of experience in the certification and approval of medical devices, we offer in-depth knowledge and practice-oriented solutions. Our experts know the challenges and requirements of the market inside out and are on hand to provide you with advice and support.
Individual Advice and Support
We accompany you personally and individually through the entire approval process. From the initial idea to the market launch and beyond, we are at your disposal as a reliable partner and develop customized strategies for your success.
International Presence and Networks
Through our branches in the USA, the UK and Brazil, we offer you access to important international markets. Our global network and in-depth knowledge of local regulatory requirements make it easier for you to access markets and ensure your competitiveness.
4 Hurdles in the approval of medical devices
Complexity
The approval process for medical devices is highly complex and requires specialist knowledge in order to be carried out efficiently and without errors. Professional handling ensures that no valuable time is lost and that all regulatory requirements are met quickly and correctly.
Language Barriers
The approval of medical devices in international markets requires not only compliance with local regulatory requirements, but also all documentation and communication in the respective national language.
Time Expense
The medical device approval process is complex and time-consuming. Particularly in an international context, it often requires a local contact person who is familiar with the specific regulatory requirements and the national language.
Costs
The approval of medical devices not only requires time and resources, but can also be associated with considerable costs. Especially if you are targeting several markets, both the effort and the financial burden of obtaining approval and meeting regulatory requirements increase.
Fallstudien: Unsere Erfolgsgeschichten
Effiziente FDA-Strategie eines Dentalunternehmens mit MEDAGENT
Ein führendes Dentalunternehmen, entwickelte eine neue Generation von CAD/CAM-Blöcken für die Herstellung von Zahnersatz. Um diese erfolgreich auf den US-Markt zu bringen, mussten die regulatorischen Anforderungen der FDA erfüllt werden.
Schnelle ISO 13485 Zertifizierung und MDR-Konformität
Ein Kleinstunternehmen produziert ein Produkt der Klasse IIa. Um dieses erfolgreich auf dem europäischen Markt einführen zu können, implementierte MEDAGENT ein Qualitätsmanagementsystem nach ISO 13485 und erstellte eine technische Dokumentation gemäß der Verordnung (EU) 2017/745.
Express-Prozessvalidierung in nur 2 Wochen
Ein mittelständisches Medizinprodukteunternehmen stand vor der Herausforderung, einen neuen Fertigungsprozess innerhalb von zwei Wochen zu validieren.
Erfolgreiche FDA-Inspektion ohne Beanstandung
Ein mittelständisches Medizinprodukteunternehmen bereitete sich mit einem MOCK Audit und professioneller Begleitung von MEDAGENT auf die FDA-Inspektion vor.
Case Study
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Case Study
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Case Study
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Case Study
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- Typische Probleme bei der Zulassung und wie man sie behebt
- Die 4 Faktoren für eine reibungslose Marktzulassung
- Beispiele unserer Kunden mit konkreten Zahlen, Daten & Fakten
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Our Locations
MEDAGENT GmbH
Headquarter:
Griesweg 47
78570 Mühlheim a. D.
Germany
New Town Office:
Tuttlinger Str. 24
78579 Neuhausen o.E.
Germany
- info@medagent.de
- +49 7463 99540
MEDAGENT Inc.
264 Lafayette Road, Suite 7
Portsmouth, NH 03801
USA
- mail@medagent-usa.com
- +1 603 5702039
MEDAGENT do brazil ltda.
Rua Jurubatuba
1350 Sala 1520, Centro
São Bernardo do Campo
SP CEP 09725-210
BRAZIL
- mail@medagent-brasil.com
- +55 11 954556178
MEDAGENT INTERNATIONAL UK LIMITED
Meridian House, Bluebell Business Estate
Sheffield Park East Sussex
TN22 3HQ
UK
- mail@medagent.co.uk
- +44 1825 705321
MEDAGENT AUSTRALIA PTY LTD
Unit 9A
139 Minjungbal Drive
NSW 2486 Tweed Heads South
Australien
- australia@medagent.com
- +61 (0) 282316651