Medical Devices & Diagnostics

The continuous monitoring and reporting of incidents are both critical and necessary for compliance with health authority requirements and the improvement of medical devices and diagnostics. As newer products are marketed globally, robust systems and processes managed by seasoned experts with pan-class experience are vital for ongoing operations. ClinChoice has the people and systems to streamline data collection, processing, and analyses of incident reports to advance patient safety.

Incident Reporting

The rapidly increasing adoption of medical devices in all its forms has led to an exponential surge of incident reporting. Medical device and diagnostic manufacturers must be able to comply with the regulations with scalable teams and technology. ClinChoice offers an exemplary blend of experienced staff and industry-compliant solutions to expedite the data collection and processing of incident reports to support product improvement initiatives and enhance product safety. Our services include:

  • End-to-end case management, including triage, data entry, quality review, medical review, and submissions
  • Expedited reporting and submission
  • SME support for incident report investigation management
  • Incident reporting operations governance and reporting

Post-Market Surveillance

Harness the power of our post-market surveillance services to continuously monitor and assess the safety and performance of your medical devices. Our proactive strategies involve real-time data collection, signal detection, safety surveillance and risk management to identify potential safety issues early on. By partnering with us, you enhance your ability to address emerging concerns, meet regulatory obligations, and uphold the highest standards of patient safety. Our deliverables are:

  • Post-marketing surveillance plan
  • Post-marketing surveillance report
  • Periodic Safety Update Reports (PSUR)
  • Post-Market Clinical Follow-up (PMCF)
  • Trend analysis
  • Risk management
  • Summary of Safety and Clinical Performance (SSCP)
  • Response documents to notified bodies

Medical Device Call Center

The diversity of medical devices accessible to physicians and patients has increased the demand for specialized services to manage adverse events and product complaints. ClinChoice’s call center staff have the scientific and medical expertise to engage with stakeholders to collect incident reports related to devices and diagnostics across different classes and process them for dissemination. We ensure that every geography is supported through our 24/7 availability and multilingual support. Our in-house incident reporting operations are tightly integrated into our call center capabilities to accelerate the analysis of incident reports and submit it to health authorities.

  • Medical device call center set-up, including multilingual translation support
  • Call intake, triage, and follow-up management
  • Call and request fulfillment documentation
  • Incident reports, PCs, and information queries
  • Product use training and support
  • Medical app usage support
  • Independent quality review of calls
  • FAQ creation and maintenance
  • Product replacement and refund support, excluding logistics
  • MDCC specialist training

Explore Related Regulatory Affairs Solutions