Regulation Compliance and Management System Improvement

A medical device company came to us with a request to assist them in meeting FDA and ISO 13485 requirements; to document, implement, and audit to these standards. They received a warning letter from the FDA and an audit with several corrective actions needed. We developed a training program to design and implement all necessary process documents and build a system that would comply with all the requirements and ensure closure for FDA concerns. In two months, they succeeded in:

• Training all 100 employees on the appropriate requirements in FDA & ISO standards
• Supported procedure development and work instruction implementation to meet both
• Audited the processes to prepare for ISO registration
• Passed FDA follow up audit with no findings

Further training in Quality, Lean, process efficiency, problem solving and root cause analysis to

• Reduce new product design, implementation and manufacturing costs by 20%?
• Close out all open corrective actions
• Drive continual improvement of the medical device design and manufacturing processes