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SERVICES

TEQUIR Services

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Medical
device consulting

The pathway from design to commercialisation for a new medical device can be unclear and complex. Regulations and requirements vary by country, level of risk, specific product claims and intended use. Our medical device regulatory experts can help you gain a Deep understanding of the applicable regulations and requirements, often beyond what is available in published guidance documents and other materials.

We will work with you to design and implement a competitive and cost-effective regulatory strategy, prepare and submit a “reviewer-friendly” marketing application, and serve as your liaison from start to end, helping you to negotiate with EU, and others international regulatory agencies quickly and effectively.

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Preparation of technical
CE marking technical dossiers

We advice you in the preparation of the technical dossier applicable to your product and we plan the conformity assessment procedure that best suits your company and medical device.

  1. We prepare the clinical device design dossier, in accordance with ISO 13485.
  2. We prepare the necessary pre-clinical validation protocols and technical reports based on current standards, guidelines and regulatory technical documents, such as MDCG, IRDFH, MEDDEV, etc.
  3. We plan and carry out the clinical evaluation required for your product.
  4. We select the technical laboratories specific to the type of test.
  5. We manage the SDW manufacturing of the required samples and prepare your manufacturing specifications, including detailed drawings.
  6. We deal with technical-quality agreements with subcontractors.
  7. Our technical dossiers are structured according to Notified Bodies.
  8. We prepare technical and quality audits.
  9. We plan and carry out the follow-up and surveillance of your medical device on the market and document the post-market report.
  10. Preparation and management of clinical trials.

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Implementation of the
Quality Management System based on ISO 13485

Depending on the scope of your organization, your healthcare products and services, we document the processes and implement them, getting your quality system prepared for audit and certification.

Time is of the essence for any organization and with our consultancy you will get your certification customized and in optimal time.

We accelerate the implementation and provide training to your team based on their needs and operativity and safety in the organization criticality.

We carry out internal audits of specific departments to detect gaps with regulatory and normative compliance.

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Regulatory Technical Assistance

We advice you according to the Role of your organization as an economic operator of medical devices, Manufacturer, Distributor, Authorised Representative or Importer of medical devices.

  1. Technical documentation and management of sanitary licenses for medical devices.
  2. Communications of placing on the market.
  3. Free sale certificates.
  4. Sanitary regulation and registration of medical devices in other European countries and international agencies.
  5. Custom-made manufacturing.
  6. Consultancy and training on the regulatory aspects of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.
  7. Regulatory studies of technical and economic feasibility of medical devices under development.
  8. Risk Analysis of products according to ISO 14971/ ISO/TR 24791.
  9. Conformity assessment of products
  10. We elaborate the biological evaluation plan for your ISO 10993 medical devices.

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Cleaning and packaging of
sterile medical devices

Within the scope of our ISO 13485:2016 certified quality system, Tequir offers cleaning, conditioning, and packaging services for products to be sterilized through our ISO 7 certified controlled environment room facilities.

We perform the validation of the cleaning process and advice you in the validation process of the packaging system of the medical device.

We prepare the product for the sterilization process providing a warehouse to preserve your products.

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Regulatory Technical Assistance

The experience accumulated in both our own clinical trials and studies, and those of third parties allows us to guarantee the quality of management by simplifying the processes, reducing the start-up times of the studies, and establishing efficient communication channels to achieve continuous monitoring of the projects.

We approach your study by focusing on the clinical data needed for the device to demonstrate compliance with regulatory requirements and reach the market in the shortest possible time.

We optimize follow-up times by prioritizing the primary points, designing a clinical research plan that is satisfactory for both the investigators and the sponsor, and matching the clinical data needs of the medical device.

We optimize the time required to manage the application for your clinical study due to our proximity to existing procedures and our knowledge of the preparation of the documentation required for evaluation, both by ethics committees and health agencies.

Through direct contact with the clinical research teams, we design your clinical research project, prepare necessary documentation, manage the approval, and start the clinical evaluation of your product in the most efficient way possible.

We coordinate the clinical study between all participating centers, ethics committees and health authorities.

We monitor the clinical trial at planned periods and support the preparation of periodic safety reports and final reports.

We manage Adverse Events according to established clinical guidelines.

Rely on our management while obtaining relevant data to improve your healthcare technologies.

Cleaning and packaging of sterile medical devices

Within the scope of our ISO 13485:2016 certified quality system, Tequir has the services of cleaning, conditioning and packaging of products to be sterilized through our ISO 7 certified controlled environment room facilities.

We carry out the validation of the cleaning process and advice you on the validation process of the packaging system of the medical device.

We prepare the product for the sterilisation process and we have a warehouse to preserve your products.

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Tequir Training

We are ready to provide the training you need. We can adjust to your needs and budget and design a quality training within the regulatory environment of medical devices and quality systems.

Latest courses carried out

Seminar on the Regulation of Medical Devices.

How to prepare a medical device design dossier.

Biological evaluation of ISO 10993 products.

Implementation of ISO 13485:2016 quality systems.

Risk Management of medical devices based on ISO 14971-ISO/TR24971.

Regulation 2017/745. How to interpret the Regulation.

New horizons in Medical Devices 2023. Customised implants and in house products