Digital Services by MEDAGENT
As part of our services, we offer you holistic digital solutions that can be seamlessly integrated into your existing systems and optimize your processes in the long term.
Efficient
Our digital solutions optimize and simplify processes throughout the company by making them more efficient and transparent.
Safe
Our digital solutions ensure secure, smooth and efficient data exchange between you and MEDAGENT.
MDR-compliant
Our digital solutions support the efficient creation and management of MDR (Regulation (EU) 2017/745)-compliant documentation and compliance with other international regulatory requirements.
Customizable
Our digital solutions enable flexible, accessible training on all relevant topics in the medical device industry.
These customers use our digital services
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MEDAGENT Comply
Our solution provides companies with comprehensive and continuous regulatory compliance monitoring, ensuring that all relevant legal requirements are always met.
MEDAGENT Valiguard
Our periodic monitoring service ensures that validations always comply with current regulatory requirements and enables continuous optimization of processes, software and methods.
MEDAGENT Learn
Our online platform offers fee-based, flexible training courses on all relevant medical technology topics. These are accessible at any time and enable comprehensive further training to ensure that you are always familiar with the latest regulatory requirements and developments.
MEDAGENT FUTURA
Our digital compact solution offers comprehensive, efficient documentation that meets both MDR and all relevant international regulatory requirements. It gives you access to carefully checked, detailed technical documentation for medical devices in risk classes I, Ir, IIa and IIb.
MEDAGENT COMPLY
Your guide to regulatory compliance monitoring
MEDAGENT COMPLY offers companies comprehensive and continuous regulatory compliance monitoring, ensuring that all relevant legal requirements are always met.
Challenges in QM & Regulatory Affairs? We are your lifeline!
Reliability, continuity & time savings
MEDAGENT VALIGUARD
Validations - always compliant, always up-to-date.
Our periodic monitoring service ensures that validations always comply with current regulatory requirements. At the same time, it enables continuous optimization of processes, software and methods - for maximum efficiency and compliance.
Validation problems? We offer the answer.
During the validation review, we analyze the performance of your systems and processes in order to identify deviations at an early stage and counteract them in a targeted manner
MEDAGENT takes over the planning and implementation of necessary adaptations. We update documentation, carry out targeted tests and implement optimizations to ensure that your validations are compliant and up-to-date.
In addition to monitoring, we offer tailored advice to identify potential risks and tap into optimization potential. Our aim is to make your systems not only compliant, but also efficient and future-proof.
The strengths of Valiguard - your security in validation.
Ensuring the continuous compliance of your validations with all legal requirements. This includes regular audits and adjustments to new regulatory standards and guidelines. We guarantee that your processes and products comply with international and national regulations at all times, minimize compliance risks and strengthen the trust of your customers and partners.
Optimize the use of resources by taking over monitoring and coordination tasks. Our service relieves your teams by taking over the continuous monitoring of your validation processes. This allows your specialists to focus on their core competencies and innovative tasks while we ensure compliance with regulatory requirements. By using specialized tools and optimized processes, we increase efficiency and minimize the time spent on routine checks.
Avoiding business interruptions by identifying and rectifying potential problems at an early stage. Our proactive approach to risk minimization includes regular audits and analyses to identify and address potential risks at an early stage. Through targeted corrective actions and preventative strategies, we increase the reliability of your processes and systems, leading to improved product quality and higher customer satisfaction.
Ensuring that your processes and software keep pace with the latest technologies and best practices. We offer not only monitoring of your current systems, but also advice and support in implementing new technologies and methods. By keeping you informed of industry trends and innovative solutions, we help you to future-proof your processes. This includes the introduction of automation, the use of data analytics and the application of agile methods in product development and validation to secure competitive advantages and strengthen your market position.
MEDAGENT CHANGE
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MEDAGENT LEARN
Anywhere and at any time
Our online platform offers fee-based, flexible training courses on all relevant medical technology topics. These are accessible at any time and enable comprehensive further training to ensure that you are always familiar with the latest regulatory requirements and developments.
Flexible, practical, future-oriented - your further training in medical technology
Our online platform gives you access to training courses on all aspects of medical technology - when and where it suits you. Whether you are at work, working from home or on the move, you can adapt your learning pace to suit you and continue your education without time pressure.
Our training courses cover all relevant topics in medical technology, from regulatory requirements and quality management to current market trends. This keeps you up to date at all times and provides you with valuable specialist knowledge for your professional success.
Our content is created and regularly updated by experienced professionals to provide you with practical and application-oriented training. Benefit from in-depth insights and best practices directly from the industry.
MEDAGENT FUTURA
Tech File Service
Stay compliant with current norms and standards and free up resources for innovation! Would you like to reduce the amount of valuable time you invest in time-consuming technical documentation every day? Do you want your team to concentrate on your core competencies again and you want to be spared time-consuming and cost-intensive updates for 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. Our Tech File 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.
MEDAGENT XCHANGE
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We are your "Experts in Digitalization"
Smooth market access
Precise knowledge of the regulatory requirements in the EU, UK, Brazil and USA ensures easy market access.
Better market opportunities
We ensure that your products meet quality standards and fulfill all regulatory requirements.
Faster approval
Our experts speed up the approval process so that your products reach the market faster.
Competitive advantages
Through efficient process optimization, we support you in reducing costs and making optimum use of resources.
Minimization of risks
With MEDAGENT, you reduce the risk of delays and rejections and increase your planning security.
International expansion
With branches in Germany, the USA and Brazil, we have valuable expertise in global markets.
Individual solutions
We offer customized strategies for market access in various international regions.
Long-term success
We ensure the sustainable success of your products by supporting you throughout the entire product life cycle.
Case studies: Our success stories
30% fewer production errors
Task
A manufacturer of surgical instruments was struggling to reduce the production error rate to an acceptable level. The company found that quality controls were not efficient enough and that internal processes were not optimally coordinated.
Solution
To overcome this challenge, the company approached us to implement a comprehensive quality management system (QMS). We first conducted a thorough analysis of the existing processes to identify weaknesses. Based on these findings, we developed a customized QMS based on international standards such as ISO 13485. We trained the company's employees intensively in the new processes and carried out regular internal audits to ensure compliance with the quality guidelines. In addition, we implemented a real-time monitoring system that enabled production errors to be detected and rectified immediately.
Result
The result was impressive: within a year, the company was able to reduce the production error rate by 30%. The introduction of the new QMS not only led to a significant reduction in errors, but also to an increase in productivity and an improvement in product quality, which had a positive impact on customer satisfaction.
Faster approval due to shorter audit
Task
A medium-sized company specializing in the manufacture of dental implants was faced with the challenge of shortening the time it took to obtain market approval for its products. The audit processes often took several months, which significantly delayed the launch of new products.
Solution
The company commissioned us with the task of optimizing the entire audit process and shortening its duration. We analyzed the existing processes and identified several areas where efficiency improvements could be made. In collaboration with the company, we developed an optimized quality management system that met the requirements of ISO 13485 while taking into account the specific needs of the company. A key component was the introduction of digital tools for documenting and tracking processes, which significantly improved transparency and traceability. We also provided training to ensure that all employees were familiar with the new procedures.
Result
Thanks to these measures, the company was able to reduce the audit duration by 20%. The accelerated market approval enabled the company to react more quickly to market changes and introduce new products promptly. This not only led to a better competitive position, but also to greater satisfaction among customers and business partners.
Benefit from over 25 years of expertise
ur focus is on the medical device industry and we have extensive expertise in implementing and complying with international regulatory requirements that are critical to success in global markets. We offer you in-depth support in meeting complex regulations and standards worldwide to ensure that your products meet the highest quality and safety requirements. Through our many years of experience in working with international authorities and applying best practices in medical technology, we are able to provide you with customized solutions that meet the specific requirements of each market.
In addition, we use our experience based on recognized quality management standards to support you not only in meeting regulatory requirements, but also in optimizing your internal processes. This holistic approach helps to ensure the quality of your products while increasing your efficiency and competitiveness. Our goal is to help you achieve a smooth and successful market authorization by supporting you with our expertise and the resources of our global network.
FAQ - We are frequently asked these questions
MEDAGENT's Digital Services include digital applications and tools that optimize processes in quality management, regulatory affairs, validation, change requests, GMP & regulatory affairs training and MDR-compliant documentation.
By using digital applications, quality management processes can be made more efficient and transparent. This enables faster identification and rectification of quality problems as well as seamless documentation and tracking.
MEDAGENT's digital tools help to meet the requirements of the MDR (Medical Device Regulation) by enabling structured and standardized creation, management and archiving of the necessary documentation.
MEDAGENT offers digital training courses on GMP (Good Manufacturing Practice) and Regulatory Affairs. These training courses are flexible and customizable so that they can be tailored to the specific needs and requirements of the client.