Medical Devices

 

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.

 

Labquality and Mectalent Medical Services have merged.

Labquality Ltd and consulting company Mectalent Medical Services Ldt (MMS), both part of COR Group, have merged. The new company will continue operating under Labquality’s name and invest heavily in product development.

The merger will combine the operations of two companies that are focused on developing the quality in healthcare and social services sectors, both being top experts in their line of business: Labquality in quality assessments and quality assurance for medical laboratories as well as certification and education services and Mectalent Medical Services in medical device and IVD-device registrations worldwide. 

EU Sales 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.

Global Sales Approvals

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.

Authorized EC Representative

If you are a non-European manufacturer and intend to sell a medical device in Europe, you must appoint an authorized EC representative in the EU. We serve as an authorized EC representative for medical device manufacturers outside of the EU who are looking for registration and sales approval in the EU.

Quality Management Systems

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.

Clinical Evaluations

The clinical evaluation of a medical device is a multistage and closely regulated process. A carefully carried out process not only fulfills requirements set by the authorities, but also gives manufacturers valuable information of the device’s performance and properties.

Other services

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).

Contact us for more information

You can reach us via info@labquality.fi