Tequir will guide you during the whole development process a medical device product requires. We'll take care of the preliminary project study and its management as well as product design, verification and validation.
1. THE PROJECT AND ITS MANAGEMENT
The department of project management will perform two preliminary phases before a project is adopted by Tequir:
Once the project has been adopted, the department of project management will take charge of:
2. DESIGN
The process of development reaches from the initial idea to the placement of the product on the market and its follow-up.
It can be conceptualized in the following stages:
3. VERIFICATION
The experience of years working with technological centers, both national as European, experts in biomechanical essays and microbiological tests, laboratories for biological evaluation, centers for animal experimentation, universities and groups of investigation specialized in biomaterials and bioelectronics, have given us the necessary knowhow about current technologies that best suit your project.
The technical team of Tequir will study the essential requisites for the project and will determine those that need verification, directing the essays to be performed.
Moreover, the technical capacities for elaborating animal experiment protocols and defining verification criteria , all this in collaboration with the clinical team, permit us to obtain secure and efficient preliminary results performing animal experimentation essays. Said essays are always performed in agreement with Royal Degree 53/2013, by which the basic applicable norms for the protection of animals used in experiments and other scientific goals, including teaching, are established.
The development of surgical techniques by means of the joint collaboration between the departments of anatomy of the faculties of medicine and the implicated clinical teams in a project, permit us to validate the surgical instruments developed in specimen tests.
4. VALIDATION
Depending the planned stages of development during the initial phase of project management, the technical team will study the available clinical data that exists and will justify the required essential requisites in the Directives 93/42/CEE and 90/385/CEE, performing studies of bibliographical clinical validation, or if necessary, by means of an Clinical Trial.
Tequir I+D+i, has been one of the pioneering companies in Spain performing clinical trials for implantable devices.
Our experience in the performance of various multi-centric clinical trials in Spain, with different pathologies and involved clinical teams, has given us an applicable know-how for defining the best suited clinical trial for the product.
The technical team of Tequir will perform the following activities within the scope of clinical validation by means of a clinical trial:
Besides they:
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