Medical
Genex UK supports the medical and healthcare industry with reliable high quality solutions designed to meet the stringent requirements of medical device manufacturers, healthcare suppliers and regulated life-science environments. Operating in alignment with ISO 13485 we help customers achieve regulatory compliance with full traceability and consistent product quality.
Regulatory Compliance and Risk Management
Genex UK understands the regulatory demands of the medical sector. Our processes support compliance with UK, EU and international medical regulations helping customers navigate complex approval and audit requirements.
Our compliance focus includes:
– Support for UKCA and CE marking requirements
– Alignment with applicable MDR and regulatory frameworks
– Risk management in line with ISO 14971 principles
– Audit readiness and regulatory documentation support
This ensures confidence in both product quality and regulatory approval.
Full Aerospace Traceability and Documentation
Complete traceability is essential for airworthiness, safety, and regulatory compliance. Genex UK provides end-to-end aerospace traceability, supporting customers from raw material through to final delivery.
Our traceability systems include:
– Full batch, lot, and serial number traceability
– Material certification and conformity documentation
– Documented process history and retention
– Support for customer, regulatory, and third-party audits
This level of transparency strengthens supply chain integrity and supports long-term programme requirements.
High Quality Solutions for Demanding Aerospace Applications
Aerospace applications demand exceptional performance under extreme conditions. Genex UK delivers solutions designed for high stress, high temperature and safety critical environments supporting:
– Aircraft structures and systems
– Engine and propulsion applications
– Maintenance, Repair and Overhaul (MRO)
– Defence and specialist aerospace programmes
Our technical expertise and sector knowledge allow us to meet the evolving demands of modern aerospace manufacturing.