LabAssist Inc

Our team has over 30 years of combined experience in the Clinical Laboratory and Pharmaceutical/Medical Device Industry. Skilled in diagnostics and navigating regulations, we ensure accuracy and compliance. From research to commercialization, we're committed to delivering innovative solutions. Clinical lab services include Laboratory Directorship, CAP inspection preparation, assay validation support, standard operating procedure and competency development, laboratory and microbiology automation, CLIA licensing support and process improvement. Pharmaceutical Lab/Medical Device production services include instrument/equipment and environmental validation, environmental monitoring and audit preparation. Environmental monitoring includes air, surface, water and climatic condition studies. As for audit preparations, our team is proficient in the following ISO standards: - ISO 14644-2: Cleanrooms and associated controlled environments - ISO 13485: Medical devices Quality management systems Requirements for regulatory purposes - ISO 9001:2015: Quality Management Systems