Design of Clinical Trials for Specific Product Categories
Since the nature of each medical device is different, we can conduct a research on a full list of requirements for any given particular project in terms of designing a clinical trial useful for the regulatory and approval process. We have worked in the past in designing clinical trials as well as documenting all protocols for bioethics committee approvals.
Follow and submission of regulatory protocols
As part of any medical device design and development process we document and validate all design iterations and test results as part of a Design History File required by most regulatory agencies in the world in order to approve medical device submissions. We can help in documenting submission files for FDA, COFEPRIS (Mexico) and other regulatory agencies.
Technology Transfer Services
Once a project is finished it can be ready for release into production. We can help providing services of transferring skills, knowledge, technologies, and methods of manufacturing to enable our clients to further develop and exploit the technology into new products, processes, applications, materials or services.
Funding through grant applications
We have helped and partnered with some of our customers in order to obtain grant funds to develop their projects. Over the last years we have successfully applied for 11 grant applications for different projects medical device based projects.
We have extensive experience in patent submission in many countries and we work with patent attorneys that have a lot of experience in the field. Our firm can help you write your patent application for protecting your intellectual property rights.