Solutions tailored to your needs
Our medical device, in vitro diagnostic, and CRO experts work together to create the most efficient solutions for you. We are a team of multidisciplinary professionals with years of industry experience. Our flexible resources are ready to quickly step in to deliver prime regulatory and quality service. We always work from your unique perspective. Whether a one-time assignment or a long-term collaboration, we support you in every phase of your regulatory journey to reach your business goals.
Experience seamlessly applied to the entire regulatory life cycle of your medical device.
IVDR or MDR transition in your hands?
We provide several tools to tackle transition projects efficiently. Each transition project is different, but the process is the same:
- Identification of the gap
- Filling the gap (incl. evaluating and creating more clinical evidence when needed)
- EU registration
Digital Health
We have a dedicated DigiHealth Unit with multi-professional competence to support your journey towards sales approvals with our medical devices.
Are you expanding to new markets?
All markets have their requirements for medical devices. However, the EU CE mark or US FDA clearance/approval is sometimes sufficient evidence for market entry and sometimes an excellent start for the registration process. Just remember to keep QMS compliant.
Capacity issues?
Do you have medical devices that need to be registered to new markets, and their technical documentations need to be updated?
We can provide a professional team to work with your team as a capacity extension unit.
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Premarket
Postmarket
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Explore our services
The solid know-how and experience of Labquality’s experts bring clarity to device requirements and regulations.
Technical documentation
We can support you in getting your Quality Management System and Technical Documentation compliant with the regulations.
Regulatory Life cycle
We help medical device companies in meeting the new, comprehensive requirements and compliance expectations during the entire lifecycle of their products.
Regulatory Essentials in Health Tech
This training series provides an efficient introduction to the regulatory essentials to turn regulatory compliance into business advantage.
Clinical Investigation
Labquality provides services and expertise in the planning, preparation, and conduct of clinical investigations.