Tor 29 feb / År 42 / Nr 4 2023

Take the fast lane to regulatory compliance with MedQdoc

Most medical device companies struggle at some point in their quality management and regulatory compliance processes. Even larger companies sometimes find it difficult to fulfil medical device regulatory frameworks, and for small companies lacking resources, it is even harder.

Therese Albinsson, CEO and Senior Quality and Regulatory Advisor at MedQtech.

This is where MedQtech steps in. The experienced medical device consultancy firm helps medical device companies to fulfil regulatory compliance and quality management in a streamlined way. To support this process, MedQtech provides a cloud-based quality management system, MedQdoc, to their customers.

MedQdoc is a ready-to-go, preconfigured and validated eQMS containing over 130 templates both for quality management and technical documentation. Combining MedQdoc and consultancy services, MedQtech’s customers become more efficient regarding the quality management and regulatory work, and, as a consequence, reach market approval for their products faster.

“We have both the eQMS, as well as all the experience and expertise required to take our clients projects through the entire QA, QMS and regulatory processes. We know which pitfalls to avoid, and how to avoid them, we know what risks there are in developing medical devices”, says Therese Albinsson, CEO and Senior Quality and Regulatory Advisor at MedQtech.

For all quality and regulatory needs

Different medical device companies often need to approach quality management and regulatory work in a different manner. This means that one size does not fit all, one solution is not sufficient to cover all needs.

Thus, MedQtech has the expertise to meet all kinds of quality and regulatory needs that may occur in projects of SMEs.

“Most medical device companies benefit from having external experts onboard to support their own quality management and regulatory teams. By partnering up with us, any quality management and regulatory compliance goal can be achieved more efficiently. We are confident in our know-how and our experience, we have access to a large network of experts, and we have everything required to tailor our services to any need”, confirms There Albinsson. 

Get ahead with MedQdoc

Principally to most small and medium sized medical device manufacturers, the difficulty and the cost of QMS implementation is always one of the main issues. Therese Albinsson started to map out what really matters to most of these companies, and created a quality management system framework based on that.

This framework was a starting point for the development of MedQdoc, a cloud based, digital quality management system for medical device companies to efficiently implement and start working in a preconfigured and validated QMS.

“With MedQdoc, any medical device company can kickstart their journey towards successful QMS and regulatory compliance. The system contains everything needed, such as configurations, QMS templates, technical documentation and other functionality as required by medical device companies”, explains Albinsson.

“By following the structure of MedQdoc, you can feel confident that your QMS will meet the requirements of ISO13485, QSR and MDR/IVDR”, she concludes.