Klaus Hammer, Head of Regulatory and Quality -

Perivision                   

" I worked with Effectum Medical (EM) over a period of 2.5 years as Perivision’s Head of Regulatory and Quality.  Since Perivision had no ISO 13485 certified Q" I worked with Effectum Medical (EM) over a period of 2.5 years as Perivision’s Head of Regulatory and Quality.  Since Perivision had no ISO 13485 certified QMS and little internal regulatory expertise when starting our device development, we cooperated with EM two main objectives: first, to advise us in obtaining the MDR CE certification for VisionOne, and second, to have EM act as the "legal manufacturer" of our medical device. Both objectives were successfully achieved.

MS and little internal regulatory expertise when starting our device development, we cooperated with EM two main objectives: first, to advise us in obtaining the MDR CE certification for VisionOne, and second, to have EM act as the "legal manufacturer" of our medical device. Both objectives were successfully achieved. 

We received the CE certification last year, benefiting from a "fast track" due to EM’s previous certification history with their notified body. Due to the fast-tracking we reached MDR/CE certification approximately 12 months ahead of our time-line, which was a key benefit of our cooperation.

Additionally, our ongoing interaction with EM as the legal manufacturer continues to be smooth, both in the current sales and delivery of devices to the markets and in handling country registrations.