2022 as perceived by members of the QA, RA and CA Department By Zoya Zilberfarb VP QA&RA

One of the 6 main values of Hanita Lenses has always been quality

We have been and will always be very proud of the quality of our products, with an emphasis on safety, and helping the surgeon attain the highest level of result that he can provide to his/her patient when using our products.

Throughout 2022, the synergy between the ‘holy trinity”; i.e., Quality Assurance (QA), Regulatory Assurance (RA) and Clinical Assurance (CA) was very fruitful in many aspects.

The main achievements were:

  • CE Marking – 93/42/CEE Renewal
  • ISO 13485:2016 Renewal
  • Successful audit for Medical Device Single Audit Program (MDSAP)
  • Worldwide registration of the most advanced IOL- Intensity  
  • Publications and clinical trials with Intensity IOL

As always and even more so this year, we invested in our process in order to attain the highest quality of our products.

Our regulatory department performs continual monitoring of all of the regulations and regulatory updates regarding all changes and challenges related to each and every field in which we are involved.

As part of our daily endeavors, we strive to provide excellent service to handle complaints, engineer change orders, conduct updates of controlled documents and troubleshoot in the case of any obstacle.

This year, one of our main goals was to invest a great deal of effort in establishing worldwide post marketing clinical trials and publications of our excellent results. The clinical department’s team was expanded to ensure we follow our vision.

The QA/RA/CA department motivates the company to strive for excellence with an emphasis on regulatory compliance and high quality of the devices  

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