We are very pleased to announce that Hanita Lenses passed successfully the Medical Device Single Audit Program (MDSAP).

The 10 days audit conducted for MDSAP combined with assessment for CE and ISO 13485 by GMED.

The MDSAP allows a single audit of a medical device manufacturer’s Quality Management System (QMS), which satisfies the requirements of multiple regulatory jurisdictions.

MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.

Currently Hanita Lenses submitted for Brazil and Canadian market.