MDM Engineering
MDM Engineering Consultants is dedicated to helping clients engineer sustainable compliance solutions for the Medical Device, Pharmaceutical, and Biotechnology industries. Led by Mercedes D. Massana, the company offers expertise in systems engineering, process improvements, regulatory compliance, and more, with a mission to enable clients to market innovative products on schedule, within budget, and with regulatory adherence.
Industries
Nr. of Employees
small (1-50)
Services
Facilitation and delivery of systems engineering deliverables including requirements, architecture, hazard analysis, FMEA, integration planning, and verification/validation artifacts.
Design and implement QMS tailored to organizational processes and regulatory requirements (FDA QSR, ISO 13485).
Support for regulatory compliance including design controls, DHF remediation, complaint handling, CAPA, and preparation for regulatory audits.
Establish integrated risk management processes, generate risk management deliverables, conduct use error and hazard analyses, and create safety assurance cases.
Develop usability engineering processes, create and execute usability protocols, and generate IEC 62366-compliant usability reports and files.
External audits by subject matter experts covering QMS, design controls, DHF, vendor management, and IEC 62304 software lifecycle processes.
Facilitation and delivery of systems engineering deliverables including requirements, architecture, hazard analysis, FMEA, integration planning, and verification/validation artifacts.
Design and implement QMS tailored to organizational processes and regulatory requirements (FDA QSR, ISO 13485).
Support for regulatory compliance including design controls, DHF remediation, complaint handling, CAPA, and preparation for regulatory audits.
Establish integrated risk management processes, generate risk management deliverables, conduct use error and hazard analyses, and create safety assurance cases.
Develop usability engineering processes, create and execute usability protocols, and generate IEC 62366-compliant usability reports and files.
External audits by subject matter experts covering QMS, design controls, DHF, vendor management, and IEC 62304 software lifecycle processes.
Expertise Areas
- Quality management systems
- Regulatory compliance (FDA QSR, ISO 13485)
- Integrated risk management (ISO 14971)
- Usability engineering and human factors
Key Technologies
- ISO 13485 / FDA QSR compliance frameworks
- ISO 14971 risk management
- IEC 62304 software lifecycle processes
- IEC 62366 human factors engineering