The Certified Biomedical Auditor is a professional who understands the principles of medical device standards, regulations, directives and guidance for auditing biomedical systems associated with medical devices while using various tools and techniques to examine, question, evaluate and report on that system’s adequacy and deficiencies. A biomedical auditor analyzes all elements of the system and reports on how well it adheres to the criteria for management and control of medical device related processes for 21 CFR 820 and ISO 13485 regulations. Other geographies such as Canada, Brazil and Japan are also discussed in addition to bio compatibility and Sterilization requirements.
CBA is a good progression for CQA certified professionals working for medical device manufacturers, contract manufacturing and testing facilities. Quality professionals working for the medical device industry at all levels ranging from supplier auditors, compliance specialists to facility managers in the medical device industry will benefit from taking the CBA class for continuing education credits and to prepare for the upcoming CBA certification exams.