Medical Device Compliance, Without the Delays
Medical Device Compliance, Without the Delays
Medical Device Compliance, Without the Delays
Certivo helps medical device manufacturers stay audit-ready and ahead of strict EU MDR, FDA, and ISO requirements by centralizing compliance and automating supplier coordination.
Certivo helps medical device manufacturers stay audit-ready and ahead of strict EU MDR, FDA, and ISO requirements by centralizing compliance and automating supplier coordination.
Certivo helps medical device manufacturers stay audit-ready and ahead of strict EU MDR, FDA, and ISO requirements by centralizing compliance and automating supplier coordination.
CORA Update
CORA verifying Resistor #2828 RoHS certificate from GHK Supplies
CORA Update
CORA verifying Resistor #2828 RoHS certificate from GHK Supplies
CORA Update
CORA verifying Resistor #2828 RoHS certificate from GHK Supplies
Case Studies
Case Studies
Case Studies
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Maintain Audit-Ready Technical Files
Centralized control for MDR, FDA, and global submissions
Organizes Declarations of Conformity, test reports, and certificates
Flags missing or outdated documents before Notified Body reviews
Monitor Material and Component Compliance
Part-level visibility across the full device supply chain
Maps supplier data to REACH, RoHS, and other restricted substances lists
Automates reminders for supplier updates and re-certifications
Accelerate Market Access Timelines
Streamlined documentation delivery for approvals and audits
Generates export-ready packets for MDR, FDA, and APAC registrations
Tracks submission milestones to prevent missed approval dates
Adapt Quickly to Evolving Regulations
Extends compliance beyond launch with seamless infrastructure alignment
Monitors component-level changes impacting risk assessment or surveillance obligations
Provides historical traceability for complaint investigations and field actions
Maintain Audit-Ready Technical Files
Centralized control for MDR, FDA, and global submissions
Organizes Declarations of Conformity, test reports, and certificates
Flags missing or outdated documents before Notified Body reviews
Monitor Material and Component Compliance
Part-level visibility across the full device supply chain
Maps supplier data to REACH, RoHS, and other restricted substances lists
Automates reminders for supplier updates and re-certifications
Accelerate Market Access Timelines
Streamlined documentation delivery for approvals and audits
Generates export-ready packets for MDR, FDA, and APAC registrations
Tracks submission milestones to prevent missed approval dates
Adapt Quickly to Evolving Regulations
Extends compliance beyond launch with seamless infrastructure alignment
Monitors component-level changes impacting risk assessment or surveillance obligations
Provides historical traceability for complaint investigations and field actions
Maintain Audit-Ready Technical Files
Centralized control for MDR, FDA, and global submissions
Organizes Declarations of Conformity, test reports, and certificates
Flags missing or outdated documents before Notified Body reviews
Monitor Material and Component Compliance
Part-level visibility across the full device supply chain
Maps supplier data to REACH, RoHS, and other restricted substances lists
Automates reminders for supplier updates and re-certifications
Accelerate Market Access Timelines
Streamlined documentation delivery for approvals and audits
Generates export-ready packets for MDR, FDA, and APAC registrations
Tracks submission milestones to prevent missed approval dates
Adapt Quickly to Evolving Regulations
Extends compliance beyond launch with seamless infrastructure alignment
Monitors component-level changes impacting risk assessment or surveillance obligations
Provides historical traceability for complaint investigations and field actions
Maintain Audit-Ready Technical Files
Centralized control for MDR, FDA, and global submissions
Organizes Declarations of Conformity, test reports, and certificates
Flags missing or outdated documents before Notified Body reviews
Monitor Material and Component Compliance
Part-level visibility across the full device supply chain
Maps supplier data to REACH, RoHS, and other restricted substances lists
Automates reminders for supplier updates and re-certifications
Accelerate Market Access Timelines
Streamlined documentation delivery for approvals and audits
Generates export-ready packets for MDR, FDA, and APAC registrations
Tracks submission milestones to prevent missed approval dates
Adapt Quickly to Evolving Regulations
Extends compliance beyond launch with seamless infrastructure alignment
Monitors component-level changes impacting risk assessment or surveillance obligations
Provides historical traceability for complaint investigations and field actions
DRAG TO EXPLORE
DRAG TO EXPLORE
Common Challenges in Medical Device Compliance
Your team must manage documentation for:
Risk Management File
Risk Management File
Clinical Evaluation Report (CER)
Clinical Evaluation Report (CER)
Declaration of Conformity (DoC)
Declaration of Conformity (DoC)
Post-Market Surveillance (PMS) Plan and Reports
Post-Market Surveillance (PMS) Plan and Reports
Certivo validates and organizes all compliance records in one place — searchable, exportable, and audit-ready.
Maintain Audit-Ready Technical Files
Centralized control for MDR, FDA, and global submissions
CORA is Certivo’s intelligent compliance engine, built to interpret and structure regulatory data across jurisdictions. CORA:
Organizes Declarations of Conformity, test reports, and certificates
Flags missing or outdated documents before Notified Body reviews
Maintain Audit-Ready Technical Files
Centralized control for MDR, FDA, and global submissions
CORA is Certivo’s intelligent compliance engine, built to interpret and structure regulatory data across jurisdictions. CORA:
Organizes Declarations of Conformity, test reports, and certificates
Flags missing or outdated documents before Notified Body reviews
Monitor Material and Component Compliance
Part-level visibility across the full device supply chain
Impact :
Maps supplier data to REACH, RoHS, and other restricted substances lists
Automates reminders for supplier updates and re-certifications
Monitor Material and Component Compliance
Part-level visibility across the full device supply chain
Impact :
Maps supplier data to REACH, RoHS, and other restricted substances lists
Automates reminders for supplier updates and re-certifications
Accelerate Market Access Timelines
Streamlined documentation delivery for approvals and audits
CORA, our intelligent compliance agent, helps you:
Generates export-ready packets for MDR, FDA, and APAC registrations
Tracks submission milestones to prevent missed approval dates
Accelerate Market Access Timelines
Streamlined documentation delivery for approvals and audits
CORA, our intelligent compliance agent, helps you:
Generates export-ready packets for MDR, FDA, and APAC registrations
Tracks submission milestones to prevent missed approval dates
Adapt Quickly to Evolving Regulations
Extends compliance beyond launch with seamless infrastructure alignment
CORA, our intelligent compliance agent, helps you:
Monitors component-level changes impacting risk assessment or surveillance obligations
Provides historical traceability for complaint investigations and field actions
Adapt Quickly to Evolving Regulations
Extends compliance beyond launch with seamless infrastructure alignment
CORA, our intelligent compliance agent, helps you:
Monitors component-level changes impacting risk assessment or surveillance obligations
Provides historical traceability for complaint investigations and field actions
Common Challenges in Medical Device Compliance
Your team must manage documentation for:
Risk Management File
Risk Management File
Clinical Evaluation Report (CER)
Clinical Evaluation Report (CER)
Declaration of Conformity (DoC)
Declaration of Conformity (DoC)
Post-Market Surveillance (PMS) Plan and Reports