About Zaliance

Regulatory judgment grounded in practical experience.

Zaliance Medical Solutions is the independent consulting practice of Christopher Ford, providing regulatory and quality support with a focus on cardiovascular medical devices and digital health.

The practice draws on experience across medical device development, manufacturing, submissions, quality management, and post-market compliance.

Experience across the product lifecycle

Christopher’s career spans more than three decades in technology, manufacturing, and quality, including medical device industry roles dating to the late 1990s.

He has held quality management responsibilities within Class II and Class III device manufacturers and has provided independent consulting services for more than twenty years. His experience includes diagnostic and therapeutic devices, complex electromechanical equipment, software-controlled devices, and Software as a Medical Device.

His work has encompassed:

  • Regulatory strategy, 510(k) submissions, and technical documentation for international market access.
  • Quality system development, implementation, maintenance, and remediation.
  • Internal, supplier, contract-manufacturer, and clinical-site audits.
  • FDA and state inspection support, inspection responses, and corrective actions.
  • Complaint handling, Medical Device Reporting, CAPA, and management review.
  • Equipment, process, software, and electronic quality system validation.
  • Risk management, human factors, and design verification and validation.
  • Training development, staff training, and outsourced quality management.

A cardiovascular focus

Zaliance brings this experience to cardiovascular manufacturers and technology developers facing regulatory, evidence, and compliance decisions.

Christopher’s cardiovascular work includes compliance support alongside detailed involvement in medical device software, ambulatory ECG analysis, performance validation, and connected technologies. This combination supports engagements involving both established products and emerging capabilities.

From Ford & Associates to Zaliance

The consulting practice began as Ford & Associates in 2004. Zaliance Medical Solutions carries that history forward with a focused offering for cardiovascular technology and the organizations bringing it to market.

Direct involvement in the work

Clients work directly with Christopher to establish priorities, define deliverables, and address the technical and organizational details of the engagement.

Support may involve a specific submission or assessment, implementation of a remediation plan, or ongoing regulatory and quality management. The scope reflects the product, the organization, and the work needed.

Discuss your project.