Our compliance to
Quality
standards upholds our commitment
to customer requirements
Quality
Quality Control & Quality Assurance
SHL implements quality management systems 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 © 2023 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 © 2023 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 compliant and ISO 13485-certified manufacturing facilities
GMP compliant and ISO 13485-certified manufacturing facilities
GMP compliant and ISO 13485-certified manufacturing facilities
GMP compliant and ISO 13485-certified manufacturing facilities