Standards

Our products are manufactured in accordance to the standards as set in the European In-Vitro Diagnostic Directive 98/79/EC. This has led to the successful attainment of Annex IV Full Quality Assurance Certification and the declaration of conformity for CE marking purposes for many of our IVD products, either self-declared or through our Notified Body LNE/G-MED in France. To complete the quality assurance scheme the company has put in place a robust Quality Management and Enhancement System that has concluded in the successful attainment of ISO9001: 2008 and ISO13485: 2003 certificate by Lloyd’s Register. The company also offers a number of OTC products that have been certified by LNE/G-MED to Annex III.6 of the CE IVD directive for home use. Furthermore, the company also adheres to the US-FDA regulations and had already FDA-cleared few products for the US market. Our products are registered in numerous countries. Our regulatory team is experienced to provide all the supporting documents to register our products in more countries. 

 

 

 

 

Technical Support

For any inquiries and product assistance please contact us