Our Services
Advisory
To develop, launch and deliver a new Medtech device to the market requires deep and solid understanding of the applicable Regulatory Requirements.
Training
It is essential to stay up to date with the current requirements within the Medical Device industry to be able to develop, manufacture and distribute safe and effective medical devices to end users.
Validation
Validation, Verification and Qualification is absolutely necessary for a company that operates in regulated environments such as Medtech and Pharma.
Audit
As a Medical Device Manufacturer, you are obliged, according to ISO 13485, to audit your Quality Management System, QMS, on a regular basis.
CE Marking
Introduction of Medical Devices into the European Union (EU), requires CE Marking. The CE Marking is the certification that the device complies with the applicable MDR/IVDR and that it is safe for the user.
Regulatory issues
Different Regulatory Requirements are applicable depending on which market you are entering and on the classification of of the Medical device.
Quality assurance
ISO 13485 is the standard for a Quality Management System, QMS, for the Design and Manufacturing of Medical Devices, and it is intended to help Manufacturers (and others) to ensure the quality and safety of launched devices.
Project Management
Our highly skilled and experienced Project Managers deliver outstanding projects both large and small and create value for customers every step of the way.