Medical devices are your world, we bring them to market
Do you want to stop dealing with the complex requirements of the MDR and rely on the expertise of professionals instead? MEDAGENT ensures that you comply with all MDR requirements effortlessly and reliably.
FAST
Efficient processes and expertise speed up the approval of your medical devices and give you a competitive advantage.
Safe
MEDAGENT minimizes risks through precise preparation and submission of the required documents as well as through effective risk management.
Economical
Working with MEDAGENT leads to savings by avoiding costs due to errors or rework and optimizing the approval process.
Legally compliant
We ensure that your products meet all national and international regulatory requirements to enable a safe, compliant market launch.
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 helped these customers to gain rapid market access
Our services
Certification of QM systems
Certification & implementation of quality management systems, internal audits, external audits, MDSAP
Process optimization
Determination of the current situation and possible improvements, presentation of the target process and support with the introduction of the necessary changes
Regulatory Affairs
Support in all regulatory affairs matters, registration and approval of your medical device, CE conformity, FUTURA, FDA approval, international approval
Validation
Efficient validation strategies for your systems to ensure the safety and functionality of your products as well as process, software and method validation
Representative Services
UK Responsible Person, U.S. Agent, Brazilian Registration Holder, EU Authorized Representative, Responsible Person, Data Protection Officer
Seminars
Benefit from our knowledge by taking advantage of our seminars. We will put together a suitable program according to your individual wishes.
An audit is the first step
Europe
In order 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 for placing medical devices on the market and the manufactured medical devices meet the essential safety and performance requirements in accordance with the MDR and therefore the CE marking may be affixed. An independent testing and certification body (notified body), such as TÜV Süd, carries out an audit with various focal points. If you successfully fulfill all the necessary points, you will receive the DIN EN ISO 13485. We support you in quality management, your technical documentation and in all matters relating to the approval of your medical device on the European market.
USA
The FDA (Food and Drug Administration) is responsible for the approval and market surveillance of medical devices in the USA. The FDA does not check for complaints or violations in accordance with DIN EN ISO 13485, but in accordance with the statutory provision 21 CFR Part 820. We are happy to support you with 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 completion of FDA inspections
Worldwide
The Medical Device Single Audit Program (MDSAP) was introduced to harmonize the respective country-specific rules, laws and approval tests of DIN EN ISO 13485, Title 21 CFR Part 820 or ANVISA. Would you like to approve products outside Europe, in the USA or in Brazil? We can advise and support you in implementing the requirements of the MDSAP and guide you through the audit by an accredited Notified Body.
No matter in which European or international market you want to launch your medical device - we design, support and optimize your processes and ideas with our many years of experience and expertise.
We are the "Experts in Medical Devices"
Competitive advantages
MEDAGENT's fast and efficient approval procedures give you a head start in the market.
Risk minimization
Sound expertise and experience minimize the risk of approval errors and delays.
Customer satisfaction
The highest quality standards and timely market launches lead to satisfied customers.
Employee motivation
Relieving your employees of complex regulatory tasks increases their motivation and efficiency.
Cost savings
Precise planning and implementation save costs by avoiding unnecessary rework.
Compliance security
Constant monitoring and adherence to legal requirements guarantee maximum compliance security.
Flexibility
Adaptable strategies and individual solutions ensure smooth project execution.
Long-term partnership
MEDAGENT offers continuous support and advice for sustainable success and growth.
Your customized roadmap to certification
Are you an original equipment manufacturer (OEM) and have developed a new product that is now subject to an upcoming audit? Or are you a contract manufacturer who wants to set up and implement a new quality management system (QM system)?
We support you with our expertise and experience to ensure that your product meets the highest quality standards and that your QM system fulfills all regulatory requirements.
In a non-binding and free preliminary meeting, we analyze your specific requirements and clarify all the necessary project steps in detail together. We then put together a tailor-made team to support you directly on site and carry out an initial internal audit with you. We analyze where your company stands and which regulatory requirements need to be met.
Based on the results, we work closely with you to further develop your existing processes in order to establish economical, practice-oriented and standard-compliant procedures. In an initial analysis, we check whether the objectives defined in the internal audit have been achieved. Another qualified team takes an objective look at your processes and ensures that all requirements are met.
Post-audit processing ensures that you are optimally prepared for the final audit and successfully obtain your desired certification.
Together to success - step by step
No matter in which European or international market you want to launch your medical device - we design, support and optimize your processes and ideas with our many years of experience and expertise.
Case studies: Our success stories
Successful FDA approval for innovative CAD/CAM dental blocks with MEDAGENT
Background
A leading dental company wanted to launch a new generation of CAD/CAM blocks for the production of high-quality dentures on the US market. To enable a fast and smooth market launch, the company decided to work with MEDAGENT.
Solution:
Optimized 510(k) submission
A structured 510(k) process was carried out in order to successfully obtain approval for the CAD/CAM blocks from the U.S. Food and Drug Administration (FDA). Thanks to the close collaboration between the company and MEDAGENT's experts, the process was efficient and targeted.
- Careful preparation of documentation
MEDAGENT supported the company in compiling the necessary technical documentation, including:
- Detailed product descriptions for precise characterization of the CAD/CAM blocks
- Results from biocompatibility tests to prove the safety of the material
- Mechanical strength data demonstrating the performance of the product
- Comparative studies with already approved products to illustrate substantial equivalence
- Efficient submission
Thanks to MEDAGENT's extensive experience with 510(k) submissions, the process was accelerated and optimally aligned with FDA requirements.
- Proactive communication with the FDA
Early and continuous communication with the FDA made it possible to clarify potential queries immediately. This helped to avoid delays and make the review process efficient.
Result: Fast approval and successful market entry
- The 510(k) approval was granted significantly faster than the industry average of 6-9 months.
- The FDA confirmed the similarity with already approved CAD/CAM materials, which enabled rapid approval.
- The company was able to quickly launch the innovative CAD/CAM blocks on the US market and thus strengthen its competitive position.
Conclusion
This successful approval process shows how a strategically well thought-out approach can accelerate market entry in the USA. Decisive for the success were:
- Thorough preparation of technical documentation
- Targeted and efficient cooperation with the authorities
- Experience and expertise in the regulatory field
- Proactive communication for quick clarification of requirements
Thanks to MEDAGENT's professional support, the company was able to master the challenges of the 510(k) process with ease and establish its innovative products on the US market in a timely manner.
Successful ISO 13485 certification and MDR compliance: How a micro-enterprise managed to enter the market with MEDAGENT in just 4 months
Background
An innovative micro-enterprise with just two employees was planning to launch a Class IIa medical device on the European market. In order to meet the requirements of Regulation (EU) 2017/745 (MDR), the company needed:
- A quality management system (QMS) in accordance with ISO 13485
- Complete technical documentation for approval by a notified body
As only limited personnel resources were available and the market launch was to take place within a short period of time, an efficient and streamlined solution was required.
Challenges
- Limited human resources - The company consisted of only two people who had to manage all processes in parallel.
- Time pressure - The market launch should take place as quickly as possible without compromising the regulatory requirements.
Solution: A lean and strategic approach
MEDAGENT developed an efficient and practical strategy that was specifically tailored to the needs of small companies:
- Prioritization of tasks
- Focus on the essential elements of the QMS and technical documentation
- Creation of a clear roadmap with milestones to implement the most important requirements first
- Use of digital solutions
- Introduction of QM software for document management via SharePoint
- Automated processes to efficiently control documentation and seamlessly record evidence
- Parallel processes to save time
- Simultaneous development of the QMS and technical documentation to avoid delays
- Early involvement of the notified body to minimize queries and rework
Results: Successful completion in record time
- ISO 13485 certification successfully obtained at the first audit
- Technical documentation accepted by the Notified Body without major objections
- Overall process completed in just 4 months - faster than the industry average
Success factors
- Focusing on the essentials - concentrating on the most important processes and documents to meet regulatory requirements
- External expertise - targeted support from experienced consultants to overcome knowledge gaps
- Digitalization - use of modern tools for efficient administration and optimization of quality management
Lessons Learned
- Even the smallest companies can implement an ISO 13485-compliant QMS and MDR-compliant technical documentation in a short space of time.
- A lean, focused approach is crucial for successful certification.
- Continuous improvement of the QMS is necessary in order to remain successful in the long term.
Conclusion
MEDAGENT's structured and pragmatic approach enabled the company to meet the regulatory requirements and successfully launch its product on the market in just four months. This case study shows that with a clear focus, digital solutions and external support, even small companies can efficiently and successfully achieve ISO 13485 certification and MDR-compliant approval.
Express process validation in 2 weeks: How MEDAGENT successfully successfully guided a medical device company through strict requirements
Background
A medium-sized medical device company was faced with the challenge of validating a new manufacturing process within just two weeks. This placed high demands on planning, teamwork and compliance with regulatory requirements.
Initial situation
- Time frame: Only 2 weeks for the entire process validation
- Team: 5 employees from the areas of quality assurance, production, technology and the experts from MEDAGENT
- Challenges:
- Tight time frame for validation
- Complex manufacturing process with numerous variables
- Compliance with strict regulatory requirements
Solution: Efficient strategy for process validation
In order to successfully complete the validation within the short deadline, MEDAGENT relied on a structured and focused approach:
- Efficient teamwork and clear communication
- Short daily meetings to assess progress and quickly clarify open points
- Clear distribution of tasks via ClickUp to ensure transparency and efficiency
- Parallelization of tasks to save time
- Simultaneous execution of documentation and practical tests to avoid time losses
- Close coordination between the teams to minimize delays
- Focus on critical aspects
- Prioritization of the most important process parameters and quality attributes
- Avoiding unnecessary complexity through targeted validation strategies
- Use of experienced specialists
- Validation by experts with extensive experience to minimize sources of error
- Quick identification and resolution of potential challenges
Results
- Successful completion of the process validation within the set deadline of 2 weeks
- All defined acceptance criteria were met
- No critical deviations during the validation runs
- Complete and regulatory compliant documentation for official inspections
Lessons Learned
- Thorough preparation and detailed planning are crucial for fast and efficient implementation.
- Focusing on critical process parameters saves time without compromising quality.
- Digital tools such as ClickUp facilitate task management and speed up the validation process.
- Continuous communication within the team ensures a smooth process and prevents delays.
Conclusion
Through a clear structure, targeted prioritization and the use of experienced experts, MEDAGENT was able to successfully complete the process validation in just 2 weeks - without compromising on quality and regulatory compliance. This case study shows that efficient planning, digital tools and close collaboration can lead to a successful implementation even under time pressure
Successful FDA inspection without complaints - optimal preparation with MEDAGENT
Background
A medium-sized medical device company was faced with the challenge of successfully passing an upcoming FDA inspection. In order to be optimally prepared, the company decided to have MEDAGENT carry out a MOCK audit, followed by targeted support during the actual inspection.
Challenges
- Ensuring FDA compliance in all relevant areas
- Identification and elimination of potential weak points before the official inspection
- Sensitization and training of employees for the audit process
- Rapid implementation of necessary corrective measures
Solution: Structured preparation with MEDAGENT
- Carrying out a realistic MOCK audit
- MEDAGENT carried out a comprehensive audit simulation under real conditions in order to uncover potential problem areas at an early stage.
- Particular weaknesses were identified in the documentation of development processes and in the CAPA system.
- Creation of a detailed action plan
- Based on the audit results, MEDAGENT developed a clearly structured action plan to systematically improve all outstanding issues.
- Prioritized optimizations were implemented within a very short time.
- Intensive training for employees
- MEDAGENT organized targeted training for the relevant teams to clearly communicate the FDA requirements.
- Particular emphasis was placed on documentation processes, CAPA systems and regulatory compliance.
- Professional support during the inspection
- MEDAGENT supported the company as a strategic partner during the official FDA inspection.
- Proactive communication with the inspectors ensured transparent and structured implementation.
Results:
FDA inspection without objections
- No Form FDA 483 - no significant deviations were identified.
- No "discussion items" - the inspector saw no reason for further discussion.
- Rating: "No Action Indicated" (NAI) - the best possible result for an FDA inspection.
Success factors
- Thorough preparation through a realistic MOCK audit with targeted weak-point analysis.
- Fast and effective implementation of the identified improvements.
- Comprehensive training and sensitization of all employees involved.
- Assistance from experienced consultants who supported the company throughout the entire process.
- Proactive, transparent communication with FDA inspectors to ensure a smooth inspection process.
Conclusion
Thanks to the targeted preparation with MEDAGENT, the company was able to complete the FDA inspection with the best possible result. This case study shows that a structured approach, realistic audits and early action are crucial for successful FDA compliance.
Benefit from more than 25 years of expertise
With offices in Germany, the USA, the UK and Brazil, our team of 30 experts is a reliable partner in regulatory and process consulting for medical technology. We support over 300 international customers in bringing their products to market efficiently.
Our goal is to increase the regulatory quality and efficiency of medical technology companies through precision, diligence and innovative solutions. In this way, we provide our customers with a fast, safe and reliable way to certify their medical devices or in-vitro diagnostics (IVD).
MEDAGENT FUTURA
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