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  • Company Wide Quality Program
  • ISO 13485 Certification
  • FDA21 CFR820 Compliant Quality System
  • Design History Files (DHFs)
  • Device History Records (DHRs)
  • Device Master Records (DMRs)

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SHL is committed to providing the highest quality products and services that meet both customer expectations and international standards for medical devices and equipment. Quality to SHL means more than just fulfilling minimum requirements as we build quality into every step of our development process.

To achieve such quality standards, SHL has implemented a system that complies with FDA 21CFR Part 820 and ISO13485. This system is regularly audited by leading pharmaceutical and biotech customers and monitored by our own internal audit procedures. Furthermore, SHL has a Corrective And Preventative Action (CAPA) program that ensures we maintain quality for our products and services.

Aside from testing all materials to comply with international safety requirements ourselves, supplier evaluations are also performed according to pre-defined internal procedures and Device History Records (DHRs) are regularly maintained. As a result, we've received various awards from leading partners for our proven quality system.

SHL offer extensive experience in dealing with regulatory authorities such as the FDA and we promote a culture of continuous improvement internally to ensure the highest customer satisfaction. Our quality program relies on every employee within the company where we encourage a strong feeling of commitment which directly results in the production of higher quality products and services.

*ISO 13485 Certification (SHL Medical) | *(SHL Healthcare/Technologies)

*ISO 9001 Certification (SHL Technologies)

*The certificates are for use of SHL’s authorized individuals, and/or companies. Any use of such certificates without SHL’s prior written authorization is strictly prohibited.

 


To find out more about SHL, please email us directly at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or by using our online contact form.