Regulatory affairs
A clear regulatory path forward.
Medical device regulatory strategy and submission support for FDA, Health Canada and European market access, tailored to your device and evidence.
Explore support →Our expertise
Medical device expertise.
From strategy to execution.
Regulatory, quality, design assurance and post-market support, tailored to the device and your team.
Quality systems
A quality system that works for your team.
Build, improve and maintain a medical device quality management system with Enerxen’s ISO 13485, FDA QMSR, audit and inspection readiness support.
Explore support →Design and risk assurance
Bring quality into every design decision.
Medical device design assurance, ISO 14971 risk management, verification, validation and manufacturing quality support from Enerxen’s consulting team.
Explore support →Post-market and complaints
Turn field experience into informed action.
Enerxen supports medical device post-market surveillance, complaint investigations, PMS plans, PSURs, PMCF activities and safety risk assessment.
Explore support →European market support
Make your EU MDR work actionable.
EU MDR consulting for medical device technical documentation, clinical evaluation, post-market surveillance and notified body readiness with Enerxen.
Explore support →Remediation and CAPA
Bring structure to a difficult quality challenge.
Enerxen supports medical device remediation, FDA 483 responses, Warning Letter remediation, root cause analysis, CAPA execution and technical file improvement.
Explore support →Project delivery
Keep complex work moving forward.
Medical device regulatory and quality project support, cross-functional coordination, onsite and remote consulting, training and team knowledge transfer.
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