Quality Management Model for Medical Devices (Q3MD)

Q3MD is becoming a reference model for implementing the requirements of ISO 13485 and the MDR (Medical Device Regulation): processes, templates and accompanying documentation that enable you to offer your medical devices in an agile, process-oriented, and certifiable manner.

Why Q3MD?

Today, the situation of regulatory requirements in the context of building medical devices and medical device software is hard to ascertain for startups and established companies. Regulatory requirements are expensive to implement in terms of consulting, external audits / certification as well as operational costs due to often paper-based processes that consultants suggest.

Companies need to adhere to many guidelines, laws, regulations, recommendations, norms, and technical reports. These are presumably well-intentioned, in par also very well-made, and also live up to their claim of creating safety in the use of medical devices. However, as a huge set of requirements for quality management systems and thus also for their implementing companies, they delay or prevent innovations that are certainly needed for patients as well.

Rarely used processes that are still unimportant in the respective company phase may be poorly implemented, overloaded with requirements or banally copied from the respective standard. As soon as such processes become important and do not only have to be implemented pro forma for auditors, they paralyze operations.

For Innovation!

Q3MD is provided at no additional cost to Pertuniti customers. As a reference model, you can adopt processes, templates and other documents (e.g. the QM manual) and further adapt them to yourself (or have them adapted).

The need for QM competencies remains, as a young or established company you will realistically not be able to get by without consultancy during initial certification. However, Q3MD is designed to ensure that costs are only incurred for processes where you have specific needs - depending on your medical device, targeted USP or particular assets.

Pertuniti is not a medical quality management consulting company, our business model is cloud BPM. According to available capacities, we can often support customers in regulatory issues nevertheless.

Status

Q3MD is under construction. We are currently looking for startups to optimize Q3MD to their requirements. If you are interested in a collaboration, please contact Dr. Johannes Tenschert.

Dr. Johannes Tenschert

CEO, Process Science

+49 89 21540190
johannes.tenschert@pertuniti.de

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