Project Summary:

A manufacturer of IVD devices required support for overcoming challenges in implementing in vitro diagnostic device regulations for various countries for a Class A device with software. The manufacturer produces standalone and cloud-based software for in-vitro diagnostics in healthcare laboratory information management systems. These software systems are designed to manage the complete laboratory workflow, from testing to reporting, and are used in healthcare settings.​

The main challenges for the manufacturer was implementation of regulatory requirements for different countries involving, Peru, Argentina, Costa Rica, Mexico, Saudi, Chile, Colombia, Australia, EU, UK, NZ, SA, Ecuador, others.

Celegence Solution & Approach:

Celegence regulatory experts conducted a comprehensive analysis of the regulatory requirements for the device, both in English-speaking and non-English-speaking countries.

Here’s a Breakdown of the Accomplishments:

  • Analysis of Regulatory Requirements
  • Establishment of Regulatory Pathways
  • Certification Approach: Celegence experts determined the certification approach required for the device to meet regulatory standards in each country.
  • Detailed Documentation Requirements
  • Post Market Surveillance (PMS) Requirements
  • Penalty Clauses
  • Gap Assessment Reports: Celegence conducted gap assessments on the quality management system (QMS) and technical documentation, including software and cybersecurity requirements
  • General Safety and Performance Requirements (GSPR) Report with action plans for remediation delivered using established Celegence templates

Project Achievements

Overall, Celegence’s work demonstrated a thorough understanding of regulatory compliance requirements and a proactive approach to ensuring the device meets the necessary standards for market approval and ongoing compliance. Our use of established templates and protocols likely helped streamline the process and ensure consistency across different markets.

Project Outcomes

Celegence’s support has proven instrumental in guiding the customer through the regulatory process, identifying areas for improvement, and ultimately ensuring compliance with regulatory requirements. The regulatory pathway reports provided guidance and support for the regulatory submissions. Significant gaps were identified and successfully addressed during meeting PMS requirements, QMS documentation, and Labelling requirements.

Our expertise and thorough assessments have contributed to the customer’s success in navigating the regulatory landscape effectively.

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