Quality & Regulatory

Our non-sterile medical devices comply to the Medical Device Regulations (EU) 2017/745 and applicable harmonised standards.

Our sterile devices meet the requirements to the Medical Device Directive93/42/EEC, UK MDR 2002 and applicable harmonised standards under supervision of SGS.

We are currently in transition for the sterile devices to be MDR Certified.Our Quality Management System complies and meets the requirements of ISO 13485:2016 under supervision of SGS. We are in progress of obtaining ISO 14001 -Environmental Management Systems certification under supervision of BAB.

For medical devices manufactured by Insight Medical Products, our EC Rep is as follows;

Reporting a Serious Incident under 2017/745 Medical Device Regulations

Contact Insight Medical Products Ltd. and the Competent Authority of the Member State in which the user and/or patient is established. This is for devices manufactured by Insight Medical Products which is clearly stated on each product page. If there is a complaint for devices distributed by Insight Medical Products, please refer to instructions with the device and contact Insight Medical Products for further actions.

Carbon Emissions Statement

To support this target and demonstrate our commitment to reduce our carbon emissions, we will produce a carbon reduction plan in line with PPN 06/21.

All our emissions reductions will be primarily achieved through ambitious carbon reduction projects and offsetting carbon emissions will only be considered in cases of unavoidable emissions or residual emissions. Insight Medical Products Limited will work with its partners to establish a yearly emission reduction target and this KPI will be integrated into our reporting system to ensure annual targets are met.

Insight Medical Products Limited is committing to become Net Zero by 2050. Our carbon reduction goals align with the IPCC’s carbon reduction roadmap, following the Science-Based Target initiative (SBTi).
To continue our progress towards achieving Net Zero, we have developed a Net Zero target for 2050.

Prescription Information

Prescription Products are available from the following home delivery service providers:

Fittleworth Medical 0800 378 846

NWOS Homecare 0800 243 103

Patient Choice 0800 862 0686

ATOS Care 0800 783 1659

Also any pharmacies that offer a delivery service

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