Quality and Regulatory Affairs Manager
Developing a new medical device? Looking to enter new markets and need a sales approval? With vast expertise in registering demanding medical devices, including implantable devices, medical software as well as personal protective equipment, we help medical and in vitro diagnostic device manufacturers acquire CE markings and global regulatory approvals.
Applying for CE-marking is a demanding and often laborious puzzle that can take several weeks. We make sure that your product and application meet the strict requirements, making it easier and quicker for your company to get a sales approval in the European economic region.
Our regulatory expertise covers a wide range of countries and in addition to the EU, we have registered devices to over 40 countries including the US, Brazil, Chile, India, Iran, Japan, Russia, Singapore, South Africa, Taiwan, and the United Arab Emirates.
Together with our customers, we plan quality management systems and write quality manuals in accordance with the ISO 13485, ISO 20387, US FDA QSR, and CMDCAS standards – just to name a few.
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.
The new In Vitro Device Regulation (IVDR) will come into force on May 26th 2022. Due to its detailed and complex nature, IVDR places significant needs for both implementation and maintenance. Our strong experience in IVD test kits and instruments, medical device software and mobile applications, ensures that we can support you in getting your Quality Management System and Technical Documentation compliant with IVDR. Our expertise also covers single-use IVDs, companion diagnostics (CDx), and genetic tests.
The new EU IVDR will bring several changes and affects the IVD economic operators in the entire supply chain, like manufacturers, distributors, importers and suppliers. To support operators to comply with the new IVDR requirements, Labquality will offer an online training course consisting of six sessions.
We also provide internal quality and regulatory trainings, support with product verifications and validations, efforts towards compliance with IVDR and MDR as well as clinical performance evaluations, planning and conduction. Labquality’s experts can also take on the role of Quality Manager and Person responsible for regulatory compliance (PRRC).