Tb Biomedical Ltd

A private consultancy firm founded by Neil Evans in November 2022. As a consultant, I provide comprehensive advisory services in quality management, health and safety, and laboratory commissioning, ensuring compliance with relevant ISO standards. This includes: Quality Management: Guidance on achieving and maintaining ISO 15189 (medical laboratories), ISO 17025 (testing and calibration laboratories), ISO 20395 (PCR-specific guidelines), and ISO 15190 (laboratory safety), focusing on the implementation of robust quality management systems, technical competence, and safety protocols. Health & Safety: Advise on the integration of health and safety standards in laboratory environments, ensuring risk assessments, proper hazard management, and compliance with ISO 15190 and local regulations. Laboratory Commissioning: Assist in the commissioning of new laboratories, ensuring compliance with regulatory requirements, validating equipment functionality, and overseeing the qualification of systems. Product Review and Marketing: Conduct detailed product reviews and collaborate with marketing teams to ensure products meet regulatory standards, perform as claimed, and align with industry best practices. Data Review and Reporting: Analyze laboratory data, generate detailed reports, and provide actionable insights to ensure compliance with quality standards and regulatory requirements. Audit and Inspection: Perform audits and inspections in accordance with ISO 17020, ensuring processes are compliant and generating reports for corrective actions where necessary. Ethics Review and IRAS Submission: Provide guidance on ethics review processes, assisting with the preparation and submission of documentation to IRAS for ethics and governance approval. Our approach ensures clients adhere to international standards, maintain safety and ethical practices, and enhance operational efficiency.