LoD-Max Biotech, LLC

Quality Control consulting firm focusing on helping companies meet regulatory requirements. Specialize in helping medical device companies and laboratories. Specialties include: • 20 years of laboratory bench experience in Research and Development that encompass pharmaceutical, biotech and medical device companies • Competency in ISO 9001: Quality Management Systems Standards • Competency in ISO 13485:2016 Updates: Medical devices -- Quality management systems -- Requirements for regulatory purposes • Competency in ISO 15189: Standard for Medical laboratories • Competency in FDA 21 CFR Part 820: Quality System Regulation (QSR) • Knowledge in developing a Quality Management System (QMS) as it relates to In Vitro Diagnostics (IVD) devices and Laboratory Developed Test (LDT) • Experience in Corrective/Preventive Action (CAPA) and Non-Conformance reporting and management • Significant statistical analyses experience for root cause analysis and verification and validation studies for process, reagent, and policy improvements • Significant experience in writing, reviewing and managing of critical regulatory documents