At AMS we understand the crucial role that clinical support plays in the successful development, testing, and deployment of cutting-edge medical devices. Our commitment to excellence extends beyond the manufacturing process – we are your collaborative partner in advancing healthcare solutions.
Our clinical support approach
Expert Guidance
With a team of seasoned clinicians, researchers, and medical experts, we offer unparalleled guidance throughout the entire product development lifecycle. From the initial concept and feasibility stages to preclinical and clinical trials, our experts provide insights that help streamline your device’s journey to market approval.
Regulatory Compliance
Navigating the complex landscape of medical device regulations can be overwhelming. Our clinical support team is well-versed in global regulatory requirements and can assist you in designing and executing clinical trials that meet these standards. This ensures that your device not only meets medical needs but also adheres to legal and safety norms.
Our clinical support services
Feasibility Studies
Our clinical support begins with comprehensive feasibility studies. We conduct in-depth assessments of your device’s potential clinical applications, risks, and benefits. This early-stage collaboration aids in refining your device’s design and intended use, setting the foundation for successful development.
Clinical Trial Design and Execution
Designing a robust clinical trial is pivotal to gathering meaningful data. We are experts in protocol development, patient recruitment strategies, and site selection. By leveraging our extensive network of healthcare partners, we facilitate efficient and effective clinical trial execution.
Data Analysis and Reporting
Once clinical trials are complete, our team carries out data analysis and preparation of regulatory documentation. Our statistical experts ensure that the results are accurately interpreted and presented, supporting successful submissions to regulatory authorities.
Post-Market Surveillance
Beyond regulatory approval, we continue to stand by your side. Our post-market surveillance efforts involve monitoring the real-world performance of your device, identifying any potential issues, and collaborating on necessary improvements.
Partner with us
At AMS, we believe that successful medical device development requires a strong partnership built on expertise, collaboration, and a shared commitment to improving patient care. Our clinical support services for Woundcare and Surgical partners embody these principles, paving the way for innovative and impactful healthcare solutions.