RegTrac provides dedicated regulatory and quality support to medical device, IVD and SaMD manufacturers across the complete product lifecycle. We help organisations establish compliant systems, prepare technical documentation, manage submissions and maintain post-market compliance across global markets.
Our multidisciplinary team combines regulatory, quality, clinical and technical expertise to deliver practical solutions aligned with each product, target market and commercial objective. Whether you require support for a specific submission or an outsourced regulatory function, we provide a clear and structured pathway from development to market and beyond.
RegTrac supports medical device, IVD and SaMD organisations in developing, implementing and maintaining effective quality management systems. Our services address ISO 13485 compliance, risk-management integration, cybersecurity, internal audits and continuous improvement throughout the product lifecycle.
Achieving CE certification requires a clear regulatory strategy, compliant technical documentation and effective coordination with the Notified Body. RegTrac supports manufacturers throughout the conformity-assessment process, from initial gap assessment and classification to technical documentation preparation, submission support and ongoing maintenance.
Our specialists help establish a structured and defensible route to EU market access while reducing documentation gaps and avoidable delays.
RegTrac supports medical device manufacturers in preparing structured, evidence-based FDA submissions, including 510(k) eSTAR submissions, De Novo requests and PMA applications. Our regulatory specialists help determine the appropriate pathway, identify documentation requirements and coordinate submission preparation and responses.
Whether you’re introducing a new device or expanding into the US market, we provide practical support designed to improve submission quality, reduce avoidable deficiencies and support an efficient FDA review process.
Trust our experienced clinical team to deliver comprehensive Clinical Evaluation Documentation, supported by robust scientific evidence and detailed analysis. We help manufacturers demonstrate the safety, performance and clinical benefits of their medical devices through structured, evidence-based clinical documentation aligned with EU MDR requirements.
RegTrac supports manufacturers in preparing and reviewing performance evaluation documentation for in vitro diagnostic medical devices. Our services help structure scientific validity, analytical performance and clinical performance evidence in accordance with EU IVDR requirements.
RegTrac supports manufacturers in developing and maintaining post-market surveillance documentation and processes. We help collect, evaluate and report post-market data to monitor device safety and performance, identify emerging risks and maintain compliance throughout the product lifecycle.
RegTrac provides integrated medical device labelling and artwork support, including content development, regulatory review, multilingual coordination and lifecycle management. We help manufacturers maintain consistent and compliant labelling across EU, UK, US and other target markets.
Global footprint extensions for device product registrations in the complex landscape of dynamic international regulations can be daunting. That’s where our Global Registration Support service specializes in guiding medical device manufacturers through the intricacies of regulatory compliance for worldwide registrations, ensuring smooth market access along with license maintenance.
RegTrac provides flexible access to experienced Quality Assurance and Regulatory Affairs professionals, enabling MedTech organisations to address capability gaps, support priority projects and maintain regulatory continuity without immediately expanding permanent headcount.
We also provide PRRC support for eligible manufacturers and authorised representatives in accordance with Article 15 of the EU MDR and IVDR. Engagements are structured around the organisation’s products, responsibilities, markets and required level of support.
RegTrac provides ongoing regulatory lifecycle management to help manufacturers maintain product compliance after market entry. Our support covers change control, technical documentation maintenance, CAPA, regulatory reporting, internal audits and post-market obligations.
RegTrac supports manufacturers in preparing for Notified Body and Approved Body assessments, coordinating submissions, responding to review questions and managing nonconformities throughout the conformity-assessment process.
Our regulatory and quality specialists support the development and maintenance of medical device risk-management documentation aligned with ISO 14971 and applicable regulatory requirements.
Book a complimentary 30-minute consultation with a RegTrac regulatory specialist. We’ll discuss your product, target markets and immediate compliance priorities, then identify the most appropriate next steps.
