Quality, risk management, and compliance built on trusted data.
Data First helps medical device, IVD, pharma, biotech, and regulated manufacturing teams strengthen risk management, ISO 14971 compliance, ICH Q9 quality risk management, ISO 27001 cybersecurity governance, and post-market surveillance activities through structured evidence review, remediation support, and defensible compliance practices.
Integrated Quality & Risk Solutions
Expert consulting services for quality, regulatory, and risk management.
Data First provides expert consulting services in risk management, post-market surveillance, cybersecurity governance, complaint intelligence, CAPA oversight, supplier quality, and regulatory remediation built on traceable data and defensible decisions.
ISO 14971 & ICH Q9 Risk Management
Experienced consultants help build and remediate risk management files, facilitate hazard analyses and FMEAs, establish risk acceptability frameworks, and support defensible regulatory decisions aligned to ISO 14971 and ICH Q9 expectations.
Post-Market Surveillance, Trending & Signal Detection
Consultants support complaint trending, signal detection, PMSR and PSUR authoring, PMCF activities, post-market risk reviews, and surveillance governance programs to strengthen regulatory readiness and product oversight.
FDA 483, Usability & Audit Remediation
Expert consultants provide support for FDA 483 responses, warning letter remediation, IEC 62366 usability risk remediation, notified body findings, CAPA execution, mock audits, and sustainable quality system improvements designed to withstand inspection scrutiny.
Cybersecurity, DHF & Supplier Quality
Consultants help organizations establish cybersecurity risk management programs, supplier quality oversight, ISO 27001 aligned practices, design assurance activities, DHF and technical file remediation, audit readiness programs, and secure documentation frameworks for regulated environments.
From risk management to regulatory remediation.
Data First provides experienced consulting support for regulated organizations that need structured, traceable, and audit-ready quality and risk management practices for executive and regulatory decision-making.
Data-driven compliance and quality risk governance.
Data First helps organizations manage end-to-end quality and risk workflows including ISO 14971 risk files, cybersecurity risk management, complaint trending, CAPA effectiveness, supplier quality oversight, FDA remediation, audit readiness, and post-market surveillance governance.