Cactus will be discontinuing certification to ISO 9001, with the plan to transition to ISO 13485:2016. Targeted completion of this transition is the end of Q2 2019, with anticipated site certification assessment in Q3 2019. Concurrently, we have initiated efforts to be integrated into Cirtec Medical’s Corporate Quality Management System that is compliant with ISO 13485:2016 and FDA 21 CFR Part 820. The sites will continue to maintain separate ISO certificates, all with the intent to utilize BSI as their registrar. Anticipated transition from our current notified body (Orion) to BSI is Q1 2020.
- My Account