SURU International Pvt. Ltd
SURU manufactures CE marked medical devices in strict compliance with International manufacturing and regulatory requirements, all products are produced and packaged within state-of-the-art clean room and controlled environments in compliance with EU medical directives and Good Manufacturing Practice (cGMP).
Production facilities have been constructed and maintained in accordance with the WHO GMP requirements for cleanliness. Plant operations are maintained for high quality standards by qualified and experienced technical personnel and trained workforce. All employees are trained regularly for personal hygiene and clean room environment. Utmost attention is provided to minimize contamination from external sources.
As a part of quality assurance, we carry stringent quality testing at each & every stage of manufacturing processes; intensive In-process quality control for components assembly & packaging helps us in providing Quality products.
SURU always focuses on quality, quality process starts right from the raw material sourcing & finishes at customer satisfaction. SURU operates a quality management system compliant with the requirements of ISO 9001:2008 & ISO 13485:2003.
Comprehensive & rigorous quality inspection using physical, chemical, biological & microbiological testing at raw materials stage, during in-process & on finished product helps us in transferring 100% clinically safe products.
Well defined & documented Product Design Dossier & quality assurance procedures, protocols & reports help us in getting fastrack product approval with various regulatory authorities.
SURU routinely follows & implements the updated regulatory and quality assurance requirement guidelines set by the medical & health regulatory domains around the globe.
WHO GMP certified facility provides confidence to SURU’s customers & product users assuring safe & efficient quality products.
SURU always Designs & develops the medical devices so as to fulfill all the requirements of medical device directives. All products are designed & developed according to appropriate & specific criteria’s from various international harmonized standards like Process Standards, System Standards and Product Standard. Selection of biocompatible material is the prime factor considered during product designing.
Modern order processing and product delivery procedures facilitate a rapid response to customer requests and order shipments. This flexibility of approach allows us to manage small orders as efficiently as large bulk shipments. SURU’s marketing personnel are prompt in responding to customer inquiry & also after sale services and collecting their feedback for continuous improvements.
In the era of certification, SURU has successfully implemented Quality Management System by following and maintaining IS0 9001:2008, ISO 13485:2003, CE Marking as per European Medical Device Directive 93/42/EEC of 14 June 1993 and WHO GMP certification.