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.

Our outsourced Quality Manager service allows your organization to focus on its core functions. An external expert or team of experts works as part of your organization as long as needed. The outsourced Quality Manager will collaborate with leadership and other stakeholders and manage your quality management system and ensures regulatory compliance

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.