Our compliance to
Quality
standards upholds our commitment
to customer requirements
Quality
Quality Control & Quality Assurance
SHL implements quality management system throughout all phases of development and production to ensure consistency in all products. SHL’s quality system complies with FDA Quality System Regulation, Medical Device Regulation, and ISO 13485:2016. The system is regularly audited by customers and monitored internally through stringent processes.
© Copyright 2020 SHL Medical AG. All rights reserved
Products and concepts under various stages of development. Please contact SHL for more information.
Quality
Regulatory
SHL has established regulatory services to support our customers through the entire product life-cycle management. We have successfully assisted our partners to obtain regulatory approval in various markets worldwide.
© Copyright 2020 SHL Medical AG. All rights reserved
Products and concepts under various stages of development. Please contact SHL for more information.
Global RA team built on Center of Excellence model.
GMP- and ISO 13485-certified manufacturing facilities
GMP- and ISO 13485-certified manufacturing facilities
GMP- and ISO 13485-certified manufacturing facilities
GMP- and ISO 13485-certified manufacturing facilities