Skip to content

QA/RA Services

Make an impact by boosting your quality and regulatory operations with our QA/RA (Quality Assurance and Regulatory Affairs) services. Whether you need to outsource a Quality Manager or just need assistance in quality and regulatory topics, we are here for you. 


QA/RA Services for Medical Device Industry

The regulatory landscape is changing fast. In the EU, MDR and IVDR are fully functional, yet transitional times are still ongoing. In the EU and other markets new guidance, standard updates and new regulations come out or evolve on an almost weekly basis, thus a major additional need for regulatory and quality professionals to manage all this change is emerging. At the same time, more and more medical devices will be controlled by notified bodies, which requires a larger workforce. The number of qualified QA/RA professionals is limited, but Labquality offers you effective and tailored solutions to fulfill your needs.


Outsourced QA/RA Manager

Sometimes qualified QA/RA experts are not easily available, or you may not need a full-time QA/RA manager yet. If that is the case with you, we can provide a quality manager from our team of experts who will match your needs.


Customised QA/RA support projects

We provide single or multiple consultants to support your QA/RA operations together with your QA/RA team. The service can be customized for a special assignment of specific quality and regulatory tasks such as

  • regulative strategies due to changes in the regulative environment
  • technical documentation updates
  • new product design control support
  • global registration activities for any country, and related documentation updates


Support for Startups, Incubators and Institutions

We provide specific early-stage regulatory services tailored for startups, incubators and institutions. Operating in the medical device field may be complicated but our services allow making the right choices from Day One.

We also arrange the popular Regulatory Essentials for Health Tech training series. See more details in the pages linked below.

Explore our services

Regulatory plan

Regulatory plan

Labquality can help medical device manufacturers in creating a regulatory plan.
Qualification and classification of medical devices

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

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.
For Startups, Incubators and Institutions

For Startups, Incubators and Institutions Open

Regulatory compliance is a struggle for Health Tech innovators and startups where ever you go.


Labquality provides medical device manufacturers help with understanding the changing regulations that set the standards of quality and safety of medical devices.
NEW - Medical software

Medical software

Labquality also provides comprehensive support for medical software lifecycle.
Meeri Säily

Contact us for more information

Meeri Säily
Sales Manager

Leave a contact request