Medical Device Consulting
Our team of experts serves medical device manufacturers by providing comprehensive consulting services for, among other things, global product registration.
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Boost your Regulatory Performance
Our experts all have more than 15 years of experience in the registration, quality and product development of medical devices. We have made hundreds of registrations in over 40 countries. We also provide training related to the requirements for medical devices.
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Premarket
Postmarket
Explore our services
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.
QA/RA Services
Our QA/RA services helps medical device manufacturers with regulatory affairs and quality management systems.
Auditing services
We offer auditing services for medical device manufacturers and health tech companies.
Post-market activities
The solid know-how and experience of Labquality’s experts brings clarity to device requirements and regulations as well as post-market activities.
Global Registrations
We help manufacturers of MD and IVD devices to obtain global CE markings and regulatory approvals for medical devices.
Trainings for Medical Device and Health Tech
Labquality offers a wide range of training sessions for medical device and health tech professionals.
Data Protection
Medical device manufacturers must take data protection and risks into account as part of their QSR.
Contact us for more information
Meeri Säily
Sales Manager
meeri.saily@labquality.com