Regulatory & Quality Certifications

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.

Quality Management System

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.

CE and FDA Certification

Shimmer3 is CE certified and complies with the following standards:
• EN 300 328 V1.6.1
• EN 301 489-1 V1.9.2
• EN 301 489-3 V1.61.1

Shimmer3 sensors (IMU, GSR+, ECG, EMG, Ebio, PROTO3 and Bridge Amplifier+) are Identified as subject to the Council Directive 2014/35/EU, for the marketing of electrical equipment designed for use within certain voltage limits (Low Voltage Directive).

Shimmer Research Ltd declares that the Shimmer3 family of devices are designed and manufactured in conformity with:
• The essential requirements (Annex I) and provisions of the European Council Directive 2014/35/EU
       • And is subject to the procedure set out in Annex III, Internal Production Control, of Council Directive 2014/35/EU
• ROHS2 Directive (2011/65 EU)

Applicable Harmonised Standards:
• EN 60335:2010 Household and similar electrical appliances – safety

Shimmer3 research platform does not hold any FDA certifications, however Shimmer has successfully supported numerous OEM companies seeking FDA approval for their solution using Shimmer3 hardware. Shimmer supports customers through the process by supplying the relevant documentation as necessary. Similarly, customers looking for various CE certifications are supported through the process by Shimmer.

Verisense IMU hardware is classified as a Class I medical device in the EU, and FDA listed as a Class II, 510(k) exempt under 21 CFR 822.5050. Verisense is FCC approved.

Verisense Pulse+ is currently in beta release with select customers. On full market release Verisense Pulse+ will be applying for both EU and FDA certifications.

As with Shimmer3, Verisense users are supported by us on the path to the unique regulatory certifications their solution requires.

Data Protection

Both Shimmer3 and Verisense platforms do not have any Shimmer developed cloud-based data storage capability for remote upload or access to data. All data storage is locally developed and managed by end users and Shimmer has no visibility or access to data. For any devices being returned to Shimmer, users are explicitly advised to remove any data, as data found on devices is immediately deleted by Shimmer. Shimmer follows all EU guidelines and directives to achieve GDPR compliance.

Manufacturing Facilities

Shimmer's parent company Realtime Technologies is a contract electronic manufacturing company with state-of-the-art facilities in Dublin, Ireland and the Czech Republic. Realtime design, manufacture and integrate electronic systems for companies in industries such as aerospace and avionics, medical equipment, defence systems and transport systems. Realtime thus manufactures all Shimmer3, Verisense sensors and related accessories.

Realtime constantly invests in the latest robotic, inspection and test equipment to ensure the highest quality such as XD7500VR Jade FP X-ray inspection, Universal Fusion MPM Accela Printer, PCB pick and place fusion, Cyber optics flex, ERSA SMARTFLOW 2020. Realtime has the relevant quality certificates: AS9100 and ISO 13485 2016 and is audited annually.

Download Documents: