Turnkey Commissioning of Product Lines & Regulatory Approvals

Supply & Commission of RMT Production Machines

Revive Medical Technologies designs, builds, and supplies custom production machinery tailored to your device and process needs. From automated assembly to packaging and testing stations, we ensure each machine is installed, calibrated, and qualified for optimal performance, backed by full technical documentation and regulatory traceability.

Installation and Training

We manage smooth installation of production systems with on-site setup, functional testing, and process integration. Our tailored training programs equip your staff — from operators to engineers — with hands-on expertise, ensuring safe operation, maintenance readiness, and knowledge retention for ongoing performance.

Commissioning and Validation Support

Our team provides expert support through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes. We develop comprehensive validation protocols and reports that satisfy ISO, FDA, and CE marking requirements, ensuring your production line meets both quality and regulatory expectations.

HR Training

We conduct specialized HR training programs to align your personnel with medical device regulatory standards, QMS requirements, and Good Manufacturing Practices (GMP). From onboarding to role-specific compliance training, we ensure your team is fully prepared for audits, inspections, and day-to-day quality assurance.

Operation and Performance Qualification (OQ/PQ)

Our experts guide you through rigorous Operation and Performance Qualification processes to validate equipment and processes under real-world conditions. We generate detailed test protocols and reports to demonstrate system reliability, repeatability, and regulatory compliance.

ISO 13485 Implementation & Certification

We provide hands-on support to help you implement a compliant ISO 13485 Quality Management System from scratch or optimize your existing processes. Our services cover documentation, SOPs, internal audits, and gap assessments — all leading to successful third-party certification and sustained compliance.

Product Licensing & Regulatory Approval

Navigating global regulatory pathways is complex — we simplify it. Our team prepares and submits all necessary documentation to secure product licenses and approvals from authorities like FDA, Health Canada, CE (MDR), CDSCO, and others. We manage communication with regulators, respond to queries, and track applications to accelerate your path to commercialization.