ARA Medtech Consultancy

With 20 years experience within medical device manufacture, ARA MedTech can support you with the following quality and regulatory requirements: Implement, maintain and update the Quality Management System (QMS). Coordinate and support regulatory audits and inspections. Prepare and submit documentation for regulatory approvals. Quality Assurance Develop and implement quality policies and procedures. Review and approve product specifications, validation protocols, and risk management files. Conduct internal audits and supplier audits. Monitor and analyse quality metrics and KPIs. Risk Management Lead risk assessments (e.g., FMEA, hazard analysis). Risk management processes throughout product development and post-market activities. Product Lifecycle Management Oversee quality aspects of product development, manufacturing, and post-market surveillance. Review and approve design history files (DHFs) and technical documentation. Participate in design reviews and change control processes. CAPA & Nonconformance Manage corrective and preventive actions (CAPA). Investigate and document nonconformances and customer complaints. Implement root cause analysis and continuous improvement initiatives. Supplier & Manufacturing Oversight Qualify and monitor suppliers and contract manufacturers. Review and approve incoming inspection plans and manufacturing records. Training & Communication Train employees on quality procedures and regulatory requirements.

• Employees 1
• Founded 2021