Anonymous
Lead Consultant, Design Controls and Quality System Management Expert
Our lead regulatory consultant at MIS Fractional brings over 20 years of deep industry experience in Quality Management Systems, Design Controls, and Risk Management, with a focus on the medical device, pharmaceutical, and packaging sectors. He specializes in providing a wide range of consulting services, acting as a one-stop shop for companies needing support—whether you’re a startup with limited resources or an established manufacturer seeking strategic direction. At Maxson InSight Services (MIS), he leverages his expertise to ensure compliance, quality, and efficiency throughout the medical device lifecycle, helping clients navigate complex regulatory landscapes with confidence.
- Engineering: Design Controls, customer input obtainment, engineering drawings, and creation of specifications to support robust product development.
- Quality Assurance: Complaint handling, internal and supplier auditing, nonconforming material management, supplier quality solutions, general QMS guidance, FDA responses, warning letter mitigation, and root cause analysis to maintain compliance and quality standards.
- Risk Management: Development of risk management plans, risk analysis, design and process FMEA, and risk management reports to mitigate potential issues.
- General Services: Due diligence support, QMS design and setup, and customer support to streamline operations and ensure success.
- Specializations: Expertise in ISO 9001, ISO 13485, and ISO 14971, ensuring adherence to industry standards for quality and risk management.