Tequir

Tequir's experience with healthcare regulatory procedures and management of quality systems based on the ISO 13485 norm, accredits it as a qualified assessor for companies who require expert and secure support with product regulation matters.   

The services Tequir offers in matter of medical device product regulation and quality systems are:

• European Representative for international manufacturers who want to establish a commercial area in Europe.
• Management of warning notes, field safety notices and vigilance procedures concerning medical device products in according the MEEDEV 2.12-1 guide.
• Education in healthcare management by means of the following training courses: 
  • Medical device product regulation
  • Implementation of ISO 13485
• Procedures and files for placing medical device products on the market.
• Technical reports concerning the product.
• Implementation of ISO 13485.
• Performance of periodical audits and implementation audits.
• Management of clinical trials and monitorization.
• Preparation of a technical file concerning the products.
• Management of knowhow protection.

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:

• A study of the phases and development activities of the project, performed in collaboration with the technical department, resulting in a planning and a detailed budget, associated with each of the development activities.
• A survey of the available offers of regional, national or European financing programs, adjusted to the necessities of the project.

Once the project has been adopted, the department of project management will take charge of:

• The management of the project in the environment of the selected finance program and the elaboration of a technical and economical file.
• Protection of the project. Through  companies specialized in the protection of knowhow, Tequir will assure the future market of the product.
• Justification and selection of adequate suppliers for the activities of the project.

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:

• A study of the "state of the art" of the product and the associated regulatory frame.
• Multidisciplinary discussions and conceptualization of ideas. Different alternatives of design are addressed, and through feedback of the whole team are purified, until the best valued design is selected.
• Design of detail, by means of 3D SolidWorks design tools.
• Manufacturing of rapid prototypes, that are once more evaluated by clinical specialists.
• Discussion of production methods with our experts in manufacturing.
• Elaboration of a product manufacturing file.

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:

• Elaborates the design of the Clinical Trial Protocol together with the principal investigator, Principal Investigator Logbook (PIL).
• Prepares all the necessary documentation for evaluation by the corresponding Ethical Investigation Committees, as well as the competent HealthCare Authorities: 
  • Logbooks for data collection, DCL.
  • Principal Investigation Logbook.
  • Technical file (risk analysis, label instructions, etc.).
  • Patient Information Sheet (PIS).
  • Informed consent model.
  • Economic reports.
  • Contracts with healthcare centers.

Besides they:

• Manage the insurance policy according RD 22/2004.
• Coordinate the clinical teams and trains them in the new surgical technique.
• Manage the necessary samples.
• Monitor the clinical trial, issuing periodical reports to the competent authorities and involved Ethical Committees.
• Prepare databases in such way that the users can enter data for its final analysis.
• Manage the analysis of statistical data for the final results.

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 involving different clinical teams, has given us valuable know-how for the correct definition of the best suited clinical trial for the characteristics of the product.

Depending on the planned development stages during the management phase of the project, the technical team will study the existing clinical data and justify the Essential Requisites required in Directives 93/427CEE and 90/385/CEE, performing bibliographic validation studies or by means of the corresponding performance of a clinical trial.

The technical team of Tequir performs the following activities within the clinical validation by means of a clinical trial:

• Elaborates together with the principal investigator the design of the Clinical Trial Protocol, (PIL) principal investigator logbook. 
• Prepares all the necessary documentation, both for the evaluation of the corresponding Ethical investigation Committees (EIC) and the competent Healthcare Authorities:
  • Data collection logbooks, DCL.
  • Principal investigator logbook.
  • Technical file (risk analysis, labeling instructions, etc…).
  • Patient Information Sheet (PIS).
  • Informed consent model.
  • Economic reports.
  • Contracts with healthcare centers.

Besides they perform the following tasks:

• Manage the insurance policy according RD 22/2004.
• Coordinate the clinical teams and trains them in the new surgical technique.
• Manage the necessary samples.
• Monitor the clinical trial, issuing periodical reports to the competent authorities and involved Ethical Committees.
• Prepare databases in such way that the users can enter data for its final analysis.
• Manage the analysis of statistical data for the final results.