Quality &
Regulatory Support
Enabling global market
access through quality and
regulatory expertise.
LRE’s well established Quality Management System for Medical Devices, based on ISO 13485:2016 in alignment with 21 CFR 820 series and experience with relevant accreditations, give our customers a firm regulatory framework for product development and manufacturing. Supported by strong, proven relationships with regulatory authorities, Notified Bodies, and accredited test houses, we provide our customers with a robust framework for achieving European and global market approvals for their medical devices. This includes compliance with directives and regulations such as the MDR and IVDR for CE marking in Europe, as well as meeting requirements set by the FDA and other relevant authorities worldwide. Quality at LRE spans across all departments involved in product development and production. All activities mirror the fulfillment of quality requirements needed for safe, effective and innovative products for diagnostics, life sciences / analytics and medtech.
Competencies
- Robust supplier evaluation, auditing, and incoming inspection processes ensure consistent quality from sourcing to storage.
- Controlled change procedures and comprehensive document management ensure traceability, compliance, and risk-based impact assessment.
- Structured CAPA processes drive continuous improvement through supplier feedback, audits, and thorough verification of non-conformities.
- Quality-controlled production with lot testing and CoC-based release ensures reliable, compliant product delivery.
- ISO-compliant risk management safeguards product safety and performance throughout the lifecycle.
Cybersecurity.
We ensure your cybersecurity strategy meets the regulatory requirements of ISO 13485 and ISO 14971. Our experts guide you through secure product development, software validation, and the implementation of key protection measures such as access control, encryption, and secure update mechanisms. Post-market, we offer continuous monitoring and rapid incident response to safeguard your devices and sensitive data.