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Quality Assurance & Certification
Quality
Control System at Angiplast encompasses a comprehensive and exhaustive series
of bacteriological, chemical, physical and visual tests; and inspections at each
pertinent stage in production cycle i.e. from constant surveillance of raw materials,
intensive in-process control of all manufactured parts and sub-assemblies to final
inspection and testing of finished products. The process is systematic and fully
documented, involving trained personnel and most advanced tools and equipments.
The Company's plant has GMP (Good Manufacturing Practices) Certification. Under
aegis of ISO (International Organization for Standardization) we have successfully
installed and implemented a quality management system and are accredited by DNV
(Det Norske Veritas), the Netherlands, for ISO 9001 : 2000 certification.
All products at Angiplast are manufactured as per ISO Quality System and
most of the products are available with CE Marking as per MDD93/42/ECC
which qualifies distribution and sale in EEC (European Economic Community)
[USFDA
510(k) Registration]
Re : K012189
Trade / Device Name : Angeltouch Vented IV Adminstration
Set
Regulation Number : 880.5440
Regulation Name : Intravascular Administration
Set
Regulatory Class : II
Product Code : FPA
Dated : January 11, 2002
Received : January 15, 2002 |
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