Regulatory Affairs

Regulatory Affairs

Please download our ISO 13485 Certificate by clicking on the downloading button

ISO 13485 Certifications


In order to help us implement procedures to ensure the safety and quality of our products, we apply European directives and are certified by world leading independent inspection organization.

 

Our 3 sites are certified ISO 13485 by a global leader in Testing, Inspection and Certification.

 

Based on ISO 9001, the emphasis on continual improvement is replaced with an emphasis on meeting regulatory and customer requirements, risk management, and maintaining effective processes, namely the safe design, manufacture, and distribution of medical devices.

IS0 13485 Certification (pdf)

 

CE Certification


All our products are CE marked, fulfilling the essential requirements of European Directive 93/42/EC on medical devices as amended by European Directive 2007/47/EC.

Medical Devices Regulation (EU MDR)


The new Medical Devices Regulation (2017/745/EU) (MDR) brings EU legislation into line with technical advances, changes in medical science, and progress in law making.

 

The new Regulations create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers.

 

The MDR will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and was published in May 2017, marking the start of a three-year period of transition from the MDD.

 

The transitional period will end on 26 May 2020, the “Date of Application” (DoA) of the Regulation, from that date the MDR will apply fully.