Quality  & Regulatory System

Elcam Quality Policy

It is the Policy of Elcam Medical, to supply the customer with a package of quality dimensions most suitable to his requirements.

Our quality dimensions are:
* Constant high-performance, defect free products
* Excellent service and customer support
* Engineering innovations
* On- Time delivery
* Competitive prices

General information:

Compliance with Quality System Regulations:
Elcam Medical manufactures in a clean room environment (class 100,000, according to Federal Standard 209E. ISO 14644 class 8). Production, warehousing, components, documentation and traceability are performed in full accordance with the FDA Quality System Regulation: Title 21 CFR 820, effective from 1997.

Compliance with ISO 9001 and ISO 13485 standards:
Elcam Quality Assurance and Regulatory system complies with and is certified for ISO 9001:2000 and ISO 13485:2003 standards.

Compliance with OHSAS 18001:2007
Elcam health and safety policy is in compliance with "OHSAS 18001:2007" - Occupational health and safety management systems.

Biocompatibility Testing:
All materials in use comply with biocompatibility requirments according to ISO 10993-1: 2003 and USP Class V test requirements.

US regulatory information: 
Most of Elcam products are 510(k) cleared.
Following is a list of our 510(k) cleared products:
Stopcocks and Manifolds: 510(k) number K022895
SafePort (Former name I&S Manifold): 510(k) number K032393
H-Flow Valve: 510(k) number K034043
Y-Click: 510(k) number K060759
B-Stop: 510(k) number K053405
Closed STP & "Marvelous": 510(k) number K060231 
Double Safe & Triple Safe Stopcocks: 510(k) number K082106
Haskal Torque Device: 510K number K100425

European regulatory information: 
Most of Elcam products are CE approved.
Following is a list of our CE approved products:
Stopcocks and Manifolds
H-Flow Valve
Y-Click
B-Stop
Closed STP & "Marvelous"
Double Safe & Triple Safe Stopcocks

Audits:
Elcam's Quality system is routinely audited by regulatory authorities and customers, as well as by Elcam itself through our internal audit system.

For additional information please contact: elcamqa@elcam.co.il