Home

Welcome

Regulatory Affairs consultancy

Our Services

Regulatory

We consult on various registrations/applications worldwide. All types of medical devices for EU, FDA etc. Regulatory strategies. Regulatory affairs manger.

Quality

Quality system builds. Issue processes templates. Lead auditor. Project management. Quality assurance manager.

Education

We offer various courses such as; CE marking for medical devices, usability, software and apps etc.

Due Diligence

For investors, acquisitions and mergers. Unique insights in regulatory, quality and product development.

Standards

We offer a wide range of consultancy for product and process standards. MEDQURE participate in the following standard committees:

TK62, TK66 & TK355