Standards and Regulatory Compliance
Dr. Marlon Cruz offers comprehensive expertise in relevant standards across various industries, with a particular focus on medical devices, circular economy principles, and cybersecurity.
Standards
Dr. Marlon Cruz possesses deep expertise in a wide range of international standards and regulatory requirements, with a particular focus on the medical device sector. His comprehensive knowledge spans quality management systems, risk management, cybersecurity, and sustainability practices, enabling him to provide strategic guidance to organizations seeking to achieve compliance and drive innovation.
Medical Device Standards
ISO 13485 – Quality Management Systems
Dr. Cruz is well-versed in the implementation and maintenance of quality management systems (QMS) as per ISO 13485, the internationally recognized standard for the medical device industry. He assists clients in establishing robust QMS processes, ensuring regulatory compliance, and fostering a culture of continuous improvement.
ISO 14971 – Risk Management
Effective risk management is crucial for medical device manufacturers. Dr. Cruz leverages his expertise in ISO 14971 to help clients identify hazards, estimate and evaluate associated risks, implement control measures, and monitor their effectiveness throughout the product lifecycle.
Regulatory Compliance
With a deep understanding of regulatory frameworks across major markets, including the U.S. FDA, EU MDR/IVDR, and other international regulations, Dr. Cruz guides clients in navigating complex compliance requirements, ensuring their products meet the highest standards of safety and efficacy.
Circular Economy Standards
ISO 59000 Series
As a strong advocate for sustainability, Dr. Cruz is well-versed in the ISO 59000 series of standards, which provide guidance on implementing circular economy principles and practices. He assists organizations in transitioning towards more sustainable business models, optimizing resource utilization, and minimizing environmental impact.
Cybersecurity Standards
IEC 62304 – Medical Device Software Lifecycle Processes
In the era of connected devices and cybersecurity threats, Dr. Cruz leverages his expertise in IEC 62304 to help clients develop, maintain, and secure software components of medical devices, ensuring compliance with industry best practices.
ISO/IEC 27001 – Information Security Management
Dr. Cruz is proficient in implementing ISO/IEC 27001, the international standard for information security management systems (ISMS). He assists organizations in establishing robust cybersecurity measures, protecting sensitive data, and mitigating risks associated with cyber threats.
ANSI/AAMI SW96 – Medical Device Security
Dr. Cruz stays abreast of the latest developments in medical device cybersecurity, including the ANSI/AAMI SW96 standard, which provides guidance on addressing cybersecurity risks in device design and development.Through his comprehensive knowledge of international standards and regulatory frameworks, Dr. Marlon Cruz empowers organizations to achieve compliance, mitigate risks, and drive sustainable growth while maintaining a competitive edge in the dynamic medical device landscape.