Our extensive regulatory expertise and close cooperation with notified bodies and authorities ensure that your clinical investigations and approvals run like clockwork.
With our all-in-one service, we take care of the complete coordination of all parties involved. You have a central point of contact and can focus on your core business.
We check in advance whether a clinical investigation is necessary at all and develop the most efficient strategy for your medical device. This helps you avoid unnecessary costs and gives you full planning security.
Our structured approach and regulatory expertise significantly accelerate the path to market approval. You can be successful in the market earlier with your device.
With optimally planned studies, you can gain meaningful data for your marketing. This will help you differentiate yourself from competitors and benefit from convincing claims for your medical device.
Our seamless documentation and PMCF plans ensure your medical devices's long-term compliance. You are optimally prepared for future audits and reviews.
Conducting clinical investigations is a major challenge for many medical device manufacturers. Regulatory requirements are unclear, and a lack of expertise in study design leads to risks. Many fear unnecessary or overly complex studies that cost a lot of time and money. These uncertainties can also lead to costly delays or even failure of device approval.
We analyze your situation and develop the optimal strategy for your medical device. This includes the evaluation of alternatives to clinical investigations and the development of a customized approach.
We develop the study design completely, including calculating the sample size and defining the endpoints. In addition, we create all the necessary documents in accordance with the current regulatory requirements.
As your central partner, we coordinate all parties involved and control the entire process – from selecting suitable study centers to communicating with authorities, notified bodies, and ethics commissions.
We support you in integrating the study results into your clinical evaluation and guide you through the entire approval process.
Contact us to find the optimal way to collect your clinical data and ensure safe market approval.
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We help you develop an optimal clinical strategy, so you know what to expect during the clinical evaluation.
We help you pass approvals, audits, and reviews quickly and safely with legally compliant clinical evaluations.
Discover the Guided Clinical Evaluator, your solution for the autonomous creation of clinical evaluations.
Our support does not end with approval. We are also at your side in the areas of post-market surveillance and post-market clinical follow-up.
Automate your post-market surveillance: We take over the continuous monitoring of the relevant notifications for your devices.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops put you on equal footing with experts.
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