Business Operational Solutions
In response to the European Medical Device Regulation (MDR), which has replaced the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), medical device manufacturers are now required to implement unique device identifiers (UDI).
These stringent regulations aim to enhance patient safety, product quality, and traceability accuracy within the medical device industry. To facilitate compliance with MDR, Industrial Technology Systems Ltd (ITS) offers a comprehensive range of MDR-compliant solutions.
These solutions empower medical device manufacturers to seamlessly meet regulatory requirements while ensuring product quality and safety.
Production of UDI User Requirement Specifications: ITS assists manufacturers in creating detailed UDI User Requirement Specifications tailored to their specific needs, ensuring a solid foundation for compliance.
Automation Solutions Integrated with ERP or Databases: ITS provides automation solutions seamlessly integrated with ERP systems or databases. These solutions receive workflows and associated UDI data, streamlining processes and ensuring data accuracy.
Integration of Label Management Solutions: ITS integrates label management solutions with a robust audit trail, approval process, and archiving capabilities, ensuring accurate and compliant labelling throughout the product lifecycle.
Installation of Print Management Solutions: ITS offers print management solutions, ensuring that the right labels and data are applied to each medical device, enhancing traceability and compliance.
Vision Systems and Code Readers Implementation: To guarantee the legibility and accuracy of printed data, ITS designs and implements vision systems and code readers that validate every detail on each device or label.
21 CFR Part 11 and CFR Part 820 Compliant Database Solutions: ITS provides compliant database solutions to record UDI traceability data for each product batch, ensuring comprehensive reporting with an audit trail for regulatory compliance.
Validation Services for UDI Automation Solutions: ITS offers validation services, assuring the reliability and accuracy of UDI automation solutions in adherence to regulatory requirements.
Provision of UDI Consultancy: ITS provides expert UDI consultancy services, working closely with clients to understand their unique needs and recommending optimal solutions for achieving compliance.
Integration with Production Systems: ITS seamlessly integrates UDI-compliant solutions with production systems such as Overall Equipment Effectiveness (OEE) and situational awareness tools, enhancing operational performance and efficiency.
Success Stories
AstraZeneca’s labeller attaches pre-printed labels onto the product cartons as they pass a certain part of the line. AstraZeneca is renowned for its continuous improvement culture and the need for faster, more accurate detection processes was identified as a priority.
With a rich history dating back to 1991, ITS boasts a dedicated team with extensive experience in the medical device industry.
Over the years, we have consistently delivered fully validated automated solutions aimed at enhancing product quality, patient safety, traceability, and MDR compliance.
ITS solutions are highly flexible, allowing integration with various ERP systems to facilitate the automated reception of workflows and UDI data.
Our approach is client-centric, and as an independent company, we work closely with our medical device clients, understanding their unique requirements, and recommending tailored solutions to ensure seamless regulatory compliance.
In the era of the European Medical Device Regulation, ITS stands as a trusted partner for medical device manufacturers seeking to meet the stringent requirements of MDR.
Our comprehensive MDR-compliant solutions offer not only compliance but also improved product quality, patient safety, and end-to-end traceability, ensuring that your medical devices meet the highest standards of quality and safety.