Shimmer Research Ltd

We are reinforcing our commitment to quality products delivered in a timely fashion, that’s why we want to give you a brief insight into our commitment to regulation and quality controls controls employed by Shimmer Research Ltd. to ensure we are meeting all ISO13485:2016 standards in the production of the Shimmer3 and Verisense hardware and data capture systems used in research studies and commercial applications. Shimmer has a documented quality assurance process, with a quality system independent from operations. Shimmer is audited annually by the URS regulatory body based on ISO13485:2016. In addition, for compliance with ISO13485:2016 we perform six internal audits annually. Shimmer’s Quality Management System (QMS) covers all the relevant processes such as training, internal and external auditing, system development, configuration, testing, data management, selection of third-party providers and CAPA management. The Shimmer Quality Management System (QMS) comprises of 3 layers; The Quality Manual, Quality Procedures and Quality Records, forms, reports and templates. Shimmer’s QMS complies with FDA 21 CFR Part 11, HIPPA, and GDPR rules. Shimmer’s QMS includes processes that support the development and life-cycle management including change management of GxP classified systems. All major activities within the Shimmer3 and Verisense hardware platforms are audit traceable. The Quality Manager reports to the CEO and is responsible for all aspects of quality within the company. The Quality Manager has the authority to stop work or shipments as and when considered necessary. The Quality Manager is also responsible for Regulatory Affairs but has the services of a Regulatory Consultant to advise on ensuring that all medical and general regulatory requirements and standards are complied with.