Quality & Regulatory

Design and manufacturing of medical devices puts a high constraint to manufacturers to warrant the quality of these devices. International regulations require that medical devices fulfill a given set of essential requirements before the devices can be brought on the market and put into service. Elana bv is offering their devices for sale in Europe, Canada and in the United States of America. Elana bv fulfills the quality requirements of ISO 13485:2012, ISO 13485:2003 CMDCAS and 21 CFR part 820 (QSR).

In today’s medical device industry many activities are outsourced to specialized companies and regulations do require that also these outsourced processes are under strict quality control of Elana as the ‘manufacturer’ of the medical devices. All Elana’s key subcontractor fulfill similarly these quality requirements by maintaining an ISO 9001:2000 ISO 13485:2003 or ISO 13485:2012  certified quality system and/or being in compliance with 21 CFR part 820.

Elana bv’s holds the following Quality System certificates:

· EN ISO 13485:2012 (/AC: 2012), #SX 60104406 0001, issued by TRLP

· ISO 13485:2003 CMDCAS, # 74 500 4746, issued by TRLP 

Elana Product Certificates:

· Directive 93/42/EEC, Annex II, excluding section 4, Full Quality Assurance System, #HD 60104405 0001

· Directive 93/42/EEC, Annex II, section 4, EC Design Examination Certificate Elana Catheter 2.0, #ID 60107999 0001

· Directive 93/42/EEC, Annex II, section 4, EC Design Examination Certificate Elana Rings, #ID 60106036 0001

· Medical Device Licence (Health Canada), Elana Surgical Kit, #75574

· Medical Device Licence (Health Canada), Elana Catheter Sizer 2.0, #81027

FDA approval:

FDA approves device to maintain blood flow during artery bypass brain surgery: HDE # H080005