Consulting

We specialize in providing comprehensive support services for companies wishing to achieve ISO 13485:2016 certification – the standard for Quality Management Systems in the medical industry. Let us provide patients with the highest quality and safe products.

In an era of diverse internal and external threats, proper information security and business continuity management ensures that threats are not your problem. Our professionals will make sure that your organization takes proper care of information security and business continuity in accordance with ISO 27001, ISO 27018, ISO 27799, ISO 22301 and others.

Our specialists will ensure that your product complies with ISO 14971. We are here to support your company in accurately identifying, analyzing and managing the risks associated with medical products. Our goal is to minimize potential risks to patients.

Also, the concern for proper risk management from the level of ISO 80001 or ISO 31000 that our specialists implement improves the safety of medical devices and the operation of the organization.

Our specialists will ensure that your products are fully compliant with the latest directives coming into force, such as NIS2 for high common cyber security – also covering the areas of Healthcare.

Continuous technological advances are associated with the development of medical software development. EIC 62304 and 82404 are international standards that provide a framework for lifecycle management of medical software, both embedded and SaMD. Join the ranks of companies that provide secure and compliant medical software.

EIC 62366 is an important standard for medical device manufacturers because it provides a framework for analyzing, specifying, developing and evaluating the usability of medical devices. Together, let’s build medical products that not only meet expectations, but also make them easier to use. By studying the interactions between users and medical devices, we can optimize their usability.

Medical products should comply with the IEC 60601 family of standards series, which is the required standard for medical device safety. Invest in the safety of your medical products, patients and personnel by designing your product in accordance with the required standards.

According to EMC standards, products should be designed to withstand electromagnetic interference and at the same time not generate interference, which is crucial to ensure safety and efficiency in medical environments.

Obtaining FDA approval is the process that allows medical devices to be marketed in the United States. Medteq.design will help you obtain FDA 510(k) approvals to bring you closer to success.

Implementation of MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) ensures the highest quality and compliance with European regulations. Whether you are just beginning the process of complying with MDR and IVDR, or need support at an advanced stage, we are here to help you every step of the way. Discover how together we can open the door to a new era of medical safety for you.

IThe implementation of directives related to the protection of personal data, and the supervision of the continuity and quality of personal data protection, is a definite domain of our specialists.