For Startups, Incubators and Institutions
Regulatory compliance is a struggle for Health Tech innovators and startups where ever you go.
Early stage regulatory services
Lean Entries as part of Labquality provides the following combination of early stage regulatory services for startups and researcher teams in your region in order to help them make right choices from Day One and saving months in time to market:
- Entries, the Digital Regulatory Runways, enables the subscribers to reach the level of know-how in minutes that traditionally takes weeks and months to build.
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- A series of webinars on the global Regulatory Essentials in Health Tech for your startups and researcher teams helps them gain the vital regulatory know-how. This translates into accelerated development cycles and improved success rates for market approvals, turning regulatory compliance from a struggle into a business advantage.
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- One-on-One Sessions on the burning regulatory needs of your startups and researcher teams. With a common language and understanding on the regulatory essentials, even an hour or two spent with our regulatory experts can help them avoid the typical pitfalls and save months in time to market.
Besides the research teams and startups, all these services can be of great value for business advisors, investors and other stakeholders who are in key positions to ensure the growth of a starting health tech company.
AdvaMed in the USA has stated:
“Medtech innovation is driven by small companies and start-ups on the cutting edge of improving patient care. In the best of times, these heavily R&D-focused firms struggle to find the financing and resources they need to navigate tough regulatory pathways in order to bring a new device or diagnostic to market.“
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Labquality can help medical device manufacturers in creating a regulatory plan.
Qualification and classification of medical devices
Our team’s versatile experience and the available tools help in bringing clarity to the challenging cases.
IVDR compliance for in-house developed tests
Laboratories developing IVDs in-house must maintain Technical Documentation and Quality Management Systems to comply with the IVDR and the national law.
EU MDR and IVDR
Labquality provides medical device manufacturers help with understanding the changing regulations that set the standards of quality and safety of medical devices.
Labquality also provides comprehensive support for medical software lifecycle.