Importance of clinical studies for medical devices
As an experienced contract research organization (CRO), we offer you tailor-made support in planning, conducting and evaluating clinical trials in accordance with the highest quality standards and regulatory requirements. Our expertise and experience in the medical device industry ensure that your products reach the market faster and more efficiently.
A specialized CRO (Contract Research Organization) for medical devices makes a decisive contribution to the success of the development and approval of new medical technologies. As with pharmaceuticals, it is also essential for medical devices in order to prove their safety and efficacy.
Providing important data on the effectiveness and safety of a product
Clinical studies are essential to prove the safety and efficacy of medical devices. This data is necessary to ensure that the products meet the requirements of the Medical Device Regulation (MDR), for example, and do not pose any unforeseen risks to patients.
Prerequisite for the conformity assessment
Medical devices cannot be placed on the market without clinical data. The MDR and the Medical Devices Implementation Act (MPDG) require manufacturers to submit clinical data that demonstrates the safety and performance of the product.
Regulatory requirements and compliance
The conduct of clinical trials is necessary to meet the regulatory requirements of the MDR and other relevant laws. Compliance with Good Clinical Practice (GCP) and ISO 14155 must be ensured as part of the implementation to ensure the protection of the test subjects and the scientific validity of the study results.
Post Market Surveillance (PMS)
After the market launch of a medical device, continuous clinical data is required to monitor long-term safety and efficacy. This is done through Post Market Clinical Follow-Up (PMCF), which is part of the PMS activities and helps to maintain product quality and patient safety.
Competitive advantage and market acceptance
Clinical studies not only provide the necessary data for approval, but also strengthen the confidence of the medical community and patients in the product. Positive study results can offer a significant competitive advantage and increase market acceptance.
Our regulatory expertise
Compliance with the Medical Device Regulation: We ensure that your study meets all the requirements of the Medical Device Regulation. From study planning to final documentation.
Compliance with ISO 14155 or Good Clinical Practice (GCP): Our processes strictly follow good clinical practice for medical devices. Thanks to our experience and diligence, we guarantee the highest quality standards in all phases of the study.
Smooth approval procedures: We manage the entire process with ethics committees and authorities. Our know-how and contacts enable efficient processing and approval of your application.
International expertise: For multinational projects, we take all relevant global regulations into account. We navigate safely through the complex requirements of different countries and regions.
Our range of services - your success
- Customized study design: We develop a concept tailored to your medical device that meets all regulatory requirements.
- Efficient subject recruitment: Fast and targeted recruitment of participants, taking into account the inclusion criteria.
- Seamless study management: from implementation to monitoring – everything from a single source. We ensure that your study runs smoothly and compliantly.
- Precise data management: State-of-the-art technologies for accurate data collection and analysis.
- Professional reporting: Clear, meaningful documentation of your results. We prepare all necessary reports and documents in accordance with regulatory requirements.
- Regulatory support: We guide you safely through all official procedures. From the application office to approval – we are your competent partner.
Place your trust in our expertise
Benefit from our specialized experience in the medical device industry. We know the challenges and special features of clinical trials for medical devices and have already successfully guided numerous projects through all the regulatory hurdles. As a member of various professional associations, we are optimally networked to successfully guide your medical device through clinical trials.
Locations
Maps
contact@mediconomics.com
+49 (0) 511 560 998-0
Call us
And what can we do for you?
Dr. (MD) Uwe Albrecht,
FIBMS, FFPM (Dis.), FICR, CSci
CEO
Headquarters
Hanover
FAQ – frequently asked questions
As a specialized CRO for medical devices, we can help you conduct clinical trials more efficiently through our expertise and efficient processes. With our specialized experience in conducting medical device studies, we optimize your study processes to minimize duration and costs. In addition, we use state-of-the-art technologies and data management systems to improve data quality and reduce monitoring and reporting efforts.
As a specialized CRO for medical devices, we have extensive knowledge of relevant regulations such as MDR, ISO 14155 and GCP to ensure that your clinical trials comply with regulatory requirements. Established quality management systems and processes ensure that all study activities are compliant. Continuous monitoring and audits during study conduct ensure compliance with regulations. With our expertise, we guide you safely through all regulatory procedures, from conception to the final report.
For medical devices, we offer you decisive advantages over conducting them in-house. Our specialized expertise and experience in the field of medical device studies, which is not available in many companies, ensures that your studies run efficiently and in compliance.
Through our broad network of trial centers and investigators, we also facilitate the conduct of multi-center trials. In addition, we take over the entire project planning and implementation so that you can fully focus on your core business.