Levox Consulting Services

Levox Consulting Services is a business service firm that helps companies to establish Quality Management Systems (QMS) for Medical Devices according to ISO standards ISO9001 and ISO13485. Also, provides auditing services to existing QMS to verify compliance against regulators such as MDSAP, EUMDR to allow commercialization of product in these markets and/or we provide resources to create processes and procedures to support QMS. We provide services to perform Root Cause Analysis (RCA) investigations for existing CAPAs, Internal Audits Findings, Deviations and Non-conformances. In addition, we provide personalized services to help companies answer External Audit Findings from Notified Bodies/Registrars/Regulators such as FDA, BSI, TUV and others. Levox Consulting Services also understand that Training is a key element for companies self-direction, therefore, we also provide training services for all QMS elements: Root Cause Analysis, CAPA, Non-Conformances, Process Validation, Microbiology, Sterilization, Clinical Affairs, Regulatory Affairs, Statistical Techniques Applied to Medical Devices, Design of Experiments (DOE), Project Management and others. We also provide Internal Audit services which includes: Scheduling, Audit Execution & Report, Audit Finding Investigations and Corrective/Preventive Actions implementation for EU MDR and MDSAP.