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.
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.

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

Copyright © 2020 SHL Medical AG. All rights reserved.
Products and concepts under various stages of development. Please contact SHL for more information.
Copyright © 2020 SHL Medical AG. All rights reserved. Products and concepts
under various stages of development. Please contact SHL for more information.