Our ISO 13485:2003 Certification is a quality management system that helps a business to produce or
supply medical related devices and services while taking care of the health problems. The key objective
here is to facilitate the conformance to medical device regulatory requirements for quality assurance. This
quality management system inherits some of the particular requirements of medical devices and excludes
some requirements that belong to ISO 9001 as they are not appropriate in the medical industry. ISO
13485 Medical Device Certification specifies equipments a Quality Management system which an
Organization needs to demonstrate ability .Though some of medical devices exclude the requirements of
ISO 9001 Regularity.
Organization can refer to international buyers for verification. A unique Certification No. Is given
on certificate which can be verifies on website.
Makes Organization systematic. Reduces dependence on individuals.
Better chances of getting National /International orders through tenders.
Cost saving due to reduced time and effort.
When systems are implemented properly the organizations profitability increases by 2-4%.
If organization adopts MIS, the top management saves 40-60% of quality time, which can be used
for expansion/better quality of life.
When MIS is in place, the monitoring of all-important parameters of business is much better and
it improves profitability by 5-10%.
This is for all medical (Orthopedic/Surgical) Manufacturers Companies.
I) Govt. Registration Copy
II) Pan Card Copy
III) Latter head Copy
IV) Organization Profile
V) Layout Plan
VI) Current Sale Copy-2
VII) Current Purchase Copy-2
VIII) Address Proof
IX) Product Detail/Services Detail
X) Employees Detail (ESI/PF Challan Copy)
XIII) Currently Working Witch States/Country
XIV) Organization Chart/Management chart
XV) Service tax/Tin Number/Vat Tax Registration copy
Market price: 25000+S.T.
SMT price: 20000+S.T.