Medical device certification from the expert for efficient and safe market launch
Medical device certification from the expert for efficient and safe market launch
Economical
With our efficient and tailor-made solutions, we optimize every step of the approval process and minimize unnecessary expenses.
RELIABLE
We provide you with reliable support throughout the entire product life cycle - from the initial idea to approval and market surveillance after launch.
Efficient
We use modern technologies to optimize all processes, create transparency and improve collaboration. Our digital tools enable seamless communication, fast decision-making and precise coordination of all steps in the project process.
IN PARTNERSHIP
MEDAGENT is characterized by a cooperative partnership based on trust, transparency and long-term success. Our long-standing customer relationships are the result of our commitment to managing each project individually and with the utmost care.
Reaching your goal with MEDAGENT: your medical devices from the idea to approval.
MEDAGENT - your strategic partner for quality management, regulatory requirements, process and software validation and quality testing in the field of medical devices.
With our offices in Germany, the USA, Brazil and the UK, we offer you a highly qualified team and the specialist expertise you need to operate successfully in international target markets. We accompany you with commitment and expertise from the initial idea through to the successful market launch of your products and provide you with advice and support throughout the entire product life cycle - for smooth, compliant and sustainable market positioning.
We have made it easier for these customers to access the market
GMP, quality management & process optimization
Regulatory Affairs & International Approvals
Global Compliance Services
Digital Services
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.
Your success with our support
Comprehensive expertise
Many years of experience in the approval of medical devices.
High quality standards
Compliant and practice-oriented processes.
International network
Subsidiaries in Germany, the USA, Brazil and the UK.
Continuous support
Support throughout the entire product life cycle and beyond.
Individual advice
Customized solutions for individual requirements.
Integrity
Maximum transparency and neutrality .
Future-oriented solutions
Compliant technical documentation by subscription.
Fast response time
Responsiveness as part of our service promise.
The best decision we could have made
Case studies: Our success stories
Efficient FDA strategy of a dental company with MEDAGENT
A leading dental company developed a new generation of CAD/CAM blocks for the manufacture of dental prostheses. In order to successfully launch these on the US market, the regulatory requirements of the FDA had to be met.
Fast ISO 13485 certification and MDR compliance
A micro-enterprise produces a class IIa product. In order to successfully launch this on the European market, MEDAGENT implemented a quality management system in accordance with ISO 13485 and prepared technical documentation in accordance with Regulation (EU) 2017/745.
Express process validation in just 2 weeks
A medium-sized medical device company was faced with the challenge of validating a new production process within two weeks.
Successful FDA inspection with no objections
A medium-sized medical device company prepared for the FDA inspection with a MOCK audit and professional support from MEDAGENT.
Case Study
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Case Study
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Case Study
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Case Study
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- Typical problems with approval and how to solve them
- The 4 factors for smooth market approval
- Examples from our customers with specific facts, figures and data
Figures that speak for themselves
Our locations
Are you looking for a trustworthy partner who can place your products on the market flexibly and efficiently, but you lack a corresponding network or knowledge of the regulatory requirements for market approval? Then we are the ideal partner for you! With our branch offices and representative services, we take care of the entire approval process and act as your direct correspondent with the national authorities.
MEDAGENT GmbH
Headquarters:
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