Regulatory Affairs
Are you developing new medical devices and need help with registration and approval? Or do you have to provide new evidence for your tried and tested products due to changes in regulations? Are you planning to conquer new markets and market your products internationally? – Then you can rely on our experience and know-how as a service provider in regulatory matters. We would be happy to help you with the preparation of your technical documentation!
Our RA team supports you quickly and flexibly in the management and coordination of all legally required regulatory and normative activities that have to be taken into account in the introduction and approval of medical devices on a national and international level. The implementation of small and large as well as international projects is our daily practice.
CE-Conformity
THIS IS HOW WE TAKE CARE TAKE CARE OF THE APPROVAL OF YOUR PRODUCTS
1. PREPARATION
2. PREPARATION OF THE TECHNICAL DOCUMENTATION
In the second step, we consider the basic registration requirements of the respective country in which your products are to be placed on the market. In addition, we find out in which risk class your products are to be classified, so that on this basis and on the basis of the information provided by you, we can find out in a team what the status of your documents is. Now we know your status quo and can, if necessary, generate additional evidence together with you. In doing so, we rely on many years of always up-to-date expertise as well as on the knowledge gained from numerous comparable projects and, last but not least, on our comprehensive knowledge of standards. Among other things, the preparation of the following documents is one of our core competencies:
– Risk analysis and assessment
– Clinical evaluation including database and technical literature research as well as evaluation
– Biological evaluation
– Planning of post market surveillance activities and evaluation of PMS data
3. SUBMISSION OF THE DOCUMENTS
As soon as we have created your technical documentation, you will receive it back for review and approval. After your positive feedback, you then submit your complete technical documentation directly to the notified body/competent authority or we take over this service for you.
4. TRACKING AND FEEDBACK
In the event of queries from the notified body or competent authority, we will of course provide you with advice and assistance and, if necessary, adapt your technical documentation in accordance with the feedback or deviations received. After renewed approval on your part, the final transmission of the file to your Notified Body or auditor takes place.
5. CERTIFICATION
After a thorough review of your documents, you will receive certification and thus approval of your products with CE marking on the European market. By means of your product file, you have proven not only the safety of your products but also their effectiveness, purpose fulfillment as well as their performance and are now allowed to market them on the target market.
FUTURA
Tech File & Big Data Management Service
Do you want to reduce the valuable time you invest in complex technical documentation on a daily basis? You want your team to concentrate on your core competencies again and you want to be spared from time-consuming and cost-intensive updates for the next years? – The solution is called FUTURA.
FUTURA is our compact solution for the smooth creation and provision of your medical device technical documentation in accordance with Regulation (EU) 2017/745. As part of FUTURA, MEDAGENT uses digital transformation to make it easier for you to comply with MDR requirements. Accordingly, FUTURA as a platform connects the economic operators involved in the entire manufacturing process of medical devices with each other – in a resource-saving and future-oriented manner. With the help of FUTURA, you can hand over up to 80% of your technical documentation to us and concentrate on your core competencies, the manufacture, service and distribution of medical devices.
FUTURA is based on a systematic, generic compilation of documents that must be submitted in full to notified bodies and authorities. Documents such as material, packaging and labeling regulations, validation of reprocessing and sterilization, biocompatibility testing, and clinical evaluation can be prefabricated in a uniform structure, so that in the end the file is created in a single mouse click. – The time and cost savings are obvious.
But what are the benefits for you as a manufacturer or producer of medical devices? Why do you need FUTURA? – You are certainly familiar with the saying “There are no problems – only challenges”. Some experts even say that the word “problem” should be removed from the vocabulary altogether. This is exactly what FUTURA does.
With FUTURA, the MEDAGENT team faces the challenges that MDR brings. FUTURA exchanges solutions for problems and stands stably on two legs: Tech File Service and Big Data Management Service form the supporting pillars of a revolutionary fusion in the medical technology industry.
These are your benefits of FUTURA
- MDR-compliant creation of technical documentation
- Ensuring the consistency of a technical documentation
- Revision of the file after deviations from file review
- Automatic monitoring of up-to-dateness through continuous maintenance
- Change tracking avoids redundancies
- The fastest and, above all, most cost-effective way to obtain approval
- One-time process analysis and description provides resource conservation
- Secured know-how transfer and protection of intellectual property
- Disclosure of information only on explicit instruction of the know-how owner
- Big Data Management through processing of large, complex data volumes
- Secure data storage on an independent server in Germany
- Current, validity-monitored and reliable information distributed according to updates
On the whole, the goal of FUTURA is, on the one hand, to create the technical documentation for your medical devices and, on the other hand, to relieve your employees as much as possible by taking over a multitude of labor-intensive activities. This allows you to regain the freedom to realize the high workload caused by the day-to-day activities, but also by the implementation of the further requirements of the MDR with your existing internal resources.
Put an end to resource-intensive file generation!
Maximum efficiency in generating your technical file, MDR compliance at the push of a button – generic and yet individual. FUTURA offers all this.
FDA Approval
We help you with your internationalization strategy! Our team therefore offers you various services for the successful approval of your products in the extremely attractive US medical device market. These include, for example, the registration of your company in the USA and the entry of your products in the FDA database. We also support you in the following processes:
- Analysis and classification of your medical devices
- Analysis and identification of applicable US regulations (Guidances, Recognized Consensus Standards) and, if applicable, applicable Performance Standards
- 513(g) Request: Obtain FDA feedback on the classification and regulatory requirements of your product.
- Pre-Submission: Obtain FDA feedback on specific pre-approval issues.
- Premarket Notification 510(k); identification or evaluation of potential comparator products (Predicate Devices) and preparation and shipment of documentation.
International Approval
Take advantage of our experience on market introduction in the desired target countries.
Our experts for foreign registrations will be happy to support you.
In order to place your medical devices on the Brazilian market, registration and approval with ANVISA is required, as well as the designation of a Brazilian Registration Holder. This process can be complex and costly depending on the product risk class.
In order to place medical devices on the market in Italy, prior registration of the devices in a database maintained by the Italian Ministry of Health is mandatory. Since the registration in the database, the necessary assignment of the correct classification codes (more than 6,500 codes, description only in Italian), the preparation of the documentation as well as the communication with the Italian authorities proves to be extensive and sometimes burdensome, we offer our customers the service of the Italian authorized representative.
For further information on international approvals, we look forward to hearing from you.