WQRE (Wenmekers Quality & regulatory Expertise) was founded in 2011. WQRE will provided support to medical device companies to comply with the world wide legislation on Quality and Regulatory related aspects. Our services cover all steps of a medical device development, from the initial project idea over the design & development to certification and/or regulatory clearance.

The development, manufacture and marketing of medical devices must meet legal and regulatory requirements ensuring that the safety and security of patients and hospital staff is guaranteed at all time. In Europe, these criteria are regulated by three EU directives dealing with medical devices in general, active and/or implantable medical devices and in vitro diagnostic devices.

The development process for medical devices must result not only in a reliable and validated device but it should also be fully documented in a technical file/dossier and a design file which must demonstrate the compliance of your product with all regulatory requirements. In addition to this, all processes related to your medical device must be part of a Quality Management System to ensures that at all times the manufacturing, the marketing and the monitoring of your product complies with these specified requirements.

WQRE provides you the necessary support at all steps of the development of your product and/or in the management of all related activities. Our key services are:

We also provide a complete range of services for investors who wish to perform a due diligence and project management service for companies willing to start a complex project in the medical device area. Please do not hesitate to contact us for further information. WQRE (Wenmekers Quality & regulatory Expertise) can rely on a broad range of medical device experience.

The founder worked for Philips N.V, Medtronic, Kimberly Clark healthcare and the Notified Body Kema/Dekra. See CV