Clinical Investigations and Studies
Professional support for clinical investigations of medical devices
Hassle-Free Approval
Our extensive regulatory expertise and close cooperation with notified bodies and authorities ensure that your clinical investigations and approvals run like clockwork.
Faster Market Access
Our structured approach and regulatory expertise significantly accelerate the path to market approval. You can be successful in the market earlier with your device.
Minimal Administrative Effort
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.
Stronger Competitive Position
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.
Maximum Cost Control
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.
Long-Term Regulatory Safety
Our seamless documentation and PMCF plans ensure your medical devices's long-term compliance. You are optimally prepared for future audits and reviews.
Save time and money with lean clinical investigations and achieve safe market approval
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 help you to successfully master clinical data collection
Strategic Consulting
We analyze your specific 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.
Study Design and Documentation
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.
Project Management and Coordination
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.
Support with the approval
We support you in integrating the study results into your clinical evaluation and guide you through the entire approval process.
Further support for the clinical evaluation of your medical device
Clinical Strategy
We help you develop an optimal clinical strategy, so you know what to expect during the clinical evaluation.
Clinical Evaluation
We help you pass approvals, audits, and reviews quickly and safely with legally compliant clinical evaluations.
Guided Clinical Evaluator
Discover the Guided Clinical Evaluator – your solution for the autonomous creation of clinical evaluations.
Post-Market Surveillance and Post-Market Clinical Follow-up
Our support does not end with approval. We are also at your side in the areas of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF).
Post-Market Radar
Automate your Post-Market Surveillance: We take over the continuous monitoring of the relevant notifications for your devices.
E-Learning, Seminars, and Workshops
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops allow you to talk to experts at eye level.
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