Regulatory affairs & international approval for medical devices
We offer you customized and efficient support in the management and coordination of all regulatory and normative requirements for the national and international approval of medical devices and in-vitro diagnostics (IVD).
Time saving
Thanks to our expertise in the requirements and processes in the regulatory world, we optimize the approval process and shorten the time to market.
Risk avoidance
The dynamic and complex regulatory requirements harbor a considerable risk of error. We minimize these risks with our expertise and experience.
Cost efficiency
Through precise planning and efficient implementation of the approval process, we minimize costs and accelerate the realization of sales returns.
Access to knowledge
Thanks to our network, you benefit from specialist knowledge and up-to-date information on regulatory developments.
We have made it easier for these customers to access the market
Our services
Registration & approval
We offer you customized support for the registration and approval of your medical devices and in-vitro diagnostics, both at national and international level. We guide you through the entire approval process, from strategic planning to efficient implementation.
Provision of new evidence
We support you in providing the necessary evidence for products that have already been launched due to changes in regulatory requirements and in ensuring compliance in order to guarantee continuous approval.
Opening up new markets
We support you in opening up new markets and develop customized strategies to successfully position your products internationally. With our expertise in global regulatory requirements and market trends, we ensure that your products receive the necessary approvals fully and efficiently and establish themselves sustainably in new markets.
Technical documentation
We offer you comprehensive support in creating, structuring and optimizing your technical documentation to ensure that all relevant regulatory requirements are fully met. Our team of experts ensures that your documentation not only complies with current legal requirements, but is also prepared efficiently and accurately.
Conformity assessment procedure
Conformity assessment procedure
FDA approval
We support you in the development of your internationalization strategy! Our team offers you a variety of customized solutions to successfully register your products on the US medical device market. These include registering your company in the USA and entering your products in the FDA database. We also support you with the following processes:
- Analysis and classification of your medical devices
- Identification and evaluation of applicable US regulations (Guidances, Recognized Consensus Standards) and relevant performance standards
- 513(g) Request: Obtain FDA feedback on the classification and regulatory requirements of your product
- Pre-submission: Obtaining FDA feedback on specific questions prior to approval
- Premarket Notification 510(k): Identification and evaluation of possible comparator products (predicate devices) and preparation and submission of the required documentation
International approval
Benefit from our experience in market launches in your desired target countries. Our experts are at your side with tailor-made solutions.
Approval in Brazil
In order to successfully place your medical devices on the Brazilian market, registration and approval with ANVISA (Agência Nacional de Vigilância Sanitária) is required. In addition, a Brazilian Registration Holder must be appointed to act as the legal contact. Depending on the risk class of your product, the approval process can be complex and involve considerable costs. We therefore offer you the Brazilian Registration Holder service to make this process efficient and smooth for you. Our experts take care of all the necessary steps, from registration to approval, and ensure that your products successfully reach the Brazilian market.
Authorization in Italy
In order to place medical devices on the market in Italy, it is necessary to register the products in advance in a database managed by the Italian Ministry of Health. This process includes the correct allocation of the relevant classification codes (more than 6,500 codes described exclusively in Italian), the preparation of the necessary documentation and communication with the competent Italian authorities. As registration and the entire process can be complex and time-consuming due to the large number of requirements and the language barrier, we offer our customers the Italian authorized representative service. Our experts take care of all administrative tasks, ensure that your products are correctly classified in accordance with legal requirements and guarantee efficient communication with the Italian authorities. You can therefore rest assured that your product will be successfully approved on the Italian market.
Approval in the UK
In order to place medical devices on the market in the UK, prior registration in the database maintained by the British authorities is required. Not only must the products be correctly classified, but a large number of regulatory requirements must also be met, which have become stricter and more complex, especially after Brexit. In view of these demanding requirements, we offer our customers the UK Responsible Person (UKRP) service. As a UKRP, we take on the legal obligations for you and ensure that your products are properly registered and approved in accordance with current UK regulations. Our experienced team will take care of all administrative and regulatory tasks, including correct product classification and the preparation of complete, compliant documentation. We also ensure smooth communication with the UK authorities to make the approval process as efficient as possible.
Approval worldwide
Careful registration and approval in the respective countries is required in order to place medical devices on international markets. These regulatory requirements vary depending on the market and can pose additional challenges, particularly in complex jurisdictions. We support you with product classification, prepare all the necessary documentation and ensure efficient communication with the relevant authorities worldwide.
We are your "Experts in Regulatory Affairs"
Competitive advantages
Expertise that accelerates your market approval.
Risk avoidance
Our expertise helps you avoid mistakes and minimize delays.
Simple market development
Our network facilitates your international expansion.
Cost savings
Optimized processes for maximum efficiency and minimum costs.
Compliance security
We ensure that your medical devices meet all relevant legal requirements.
Flexibility
React quickly and efficiently to market changes and new requirements.
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.
1. careful preparation of the documents
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
2. efficient submission
Thanks to MEDAGENT's extensive experience with 510(k) submissions, the process was accelerated and optimized to meet the FDA's requirements.
3. proactive communication with the FDA
An early and continuous exchange with the FDA made it possible to clarify potential queries immediately. This helped to avoid delays and make the review process efficient.
Results
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
How a micro-enterprise managed to enter the market in just 4 months with MEDAGENT
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
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
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.
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
- Focus on the essentials - concentration 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.
MEDAGENT FUTURA
Ensure that you always remain compliant with current norms and standards and create room for innovation at the same time!
Do you want to minimize the time-consuming process of creating and maintaining technical documentation? Do you want your team to be able to focus on their core competencies while you are protected from time-consuming and costly updates in the years to come? - The solution is FUTURA.
Challenges in Regulatory Affairs? FUTURA is your lifeline!
FUTURA is our tailor-made solution for the efficient creation and provision of your technical documentation for medical devices in accordance with Regulation (EU) 2017/745. MEDAGENT uses digital transformation as part of FUTURA to make it easier for you to comply with the MDR requirements and to optimize your processes.
As a platform, FUTURA brings together all the relevant players in the entire medical device manufacturing process - in a resource-saving and sustainable way. With FUTURA, you can hand over up to 80% of the technical documentation to us so that you can concentrate on your core competencies: the manufacture, service and distribution of your products.
FUTURA is based on a structured, generic compilation of all required documents that must be submitted in full to notified bodies and authorities. Documents such as material, packaging and labelling regulations, validation of reprocessing and sterilization, biocompatibility tests and clinical evaluations can be prefabricated in a standardized structure. This makes it possible to create the file with just one mouse click. - The time and cost savings are considerable.
But what does FUTURA mean for you as a manufacturer or producer of medical devices? In an industry that is always about solving challenges, FUTURA delivers exactly that: a solution. FUTURA removes the word "problem" from your vocabulary and offers you an efficient and future-proof way to meet the requirements of the MDR.
With FUTURA, the MEDAGENT team addresses the challenges of the MDR and provides innovative solutions. The combination of Tech File Service and Big Data Management Service forms the basis for a groundbreaking development in the medical technology industry that helps you to master regulatory requirements while increasing your efficiency and competitiveness.
- MDR-compliant creation of technical documentation
- Ensuring the consistency of technical documentation
- Revision of the technical documentation following deviations from the file review
- Automatic monitoring of up-to-dateness through continuous maintenance
- Change tracking avoids redundancies
- The quickest and, above all, cheapest way to obtain approval
The main objective of FUTURA is to take over the preparation of the technical documentation for your medical devices and at the same time relieve your employees of a large number of labor-intensive tasks. In this way, you gain valuable freedom to concentrate on managing day-to-day business operations and implementing further MDR requirements with your existing internal resources.
Say goodbye to resource-intensive file creation! FUTURA offers you maximum efficiency in the creation of your technical file, ensuring MDR compliance at the touch of a button - generic, yet individually tailored to your needs. FUTURA combines flexibility and automation and enables you to meet regulatory requirements quickly and precisely.