Medical Device Compliance, Without the Delays
Medical device manufacturers operate in one of the most highly regulated industries in the world. EU MDR, FDA requirements, and ISO frameworks demand complete control over documentation, supplier engagement, and regulatory traceability — all while timelines remain critical.
Certivo centralizes compliance documentation and automates supplier coordination, helping teams stay audit-ready, aligned with evolving regulations, and ahead of schedule.
Medical device manufacturers operate in one of the most highly regulated industries in the world. EU MDR, FDA requirements, and ISO frameworks demand complete control over documentation, supplier engagement, and regulatory traceability — all while timelines remain critical.
Certivo centralizes compliance documentation and automates supplier coordination, helping teams stay audit-ready, aligned with evolving regulations, and ahead of schedule.
CORA Update
CORA verifying Resistor #2828 RoHS certificate from GHK Supplies
CORA Update
CORA verifying Resistor #2828 RoHS certificate from GHK Supplies
Medical Device Compliance, Without the Delays
Medical Device Compliance, Without the Delays
Medical device manufacturers operate in one of the most highly regulated industries in the world. EU MDR, FDA requirements, and ISO frameworks demand complete control over documentation, supplier engagement, and regulatory traceability — all while timelines remain critical.
Certivo centralizes compliance documentation and automates supplier coordination, helping teams stay audit-ready, aligned with evolving regulations, and ahead of schedule.
Medical device manufacturers operate in one of the most highly regulated industries in the world. EU MDR, FDA requirements, and ISO frameworks demand complete control over documentation, supplier engagement, and regulatory traceability — all while timelines remain critical.
Certivo centralizes compliance documentation and automates supplier coordination, helping teams stay audit-ready, aligned with evolving regulations, and ahead of schedule.
CORA Update
CORA verifying Resistor #2828 RoHS certificate from GHK Supplies
CORA Update
CORA verifying Resistor #2828 RoHS certificate from GHK Supplies
Common Challenges in Medical Device Compliance
Documentation Burden Across Global Regulations Whether launching in the EU, US, or APAC, your team must manage documentation for:
Automotive
Prop 65
Safety
PFAS Restrictions
Conflict Minerals
POPs
SCIP Notifications
OEM Customer Documentation Requirements
CoCs
Certivo validates and organizes all compliance records in one place — searchable, exportable, and audit-ready.
Common Challenges in Medical Device Compliance
Documentation Burden Across Global Regulations Whether launching in the EU, US, or APAC, your team must manage documentation for:
Automotive
Prop 65
Safety
PFAS Restrictions
Conflict Minerals
POPs
SCIP Notifications
OEM Customer Documentation Requirements
CoCs
Certivo validates and organizes all compliance records in one place — searchable, exportable, and audit-ready.
Common Challenges in Medical Device Compliance
Documentation Burden Across Global Regulations Whether launching in the EU, US, or APAC, your team must manage documentation for:
Automotive
Prop 65
Safety
PFAS Restrictions
Conflict Minerals
POPs
SCIP Notifications
OEM Customer Documentation Requirements
CoCs
Certivo validates and organizes all compliance records in one place — searchable, exportable, and audit-ready.
Certivo Addresses Key Challenges in Medical Device Compliance
Overcome regulatory obstacles with Certivo’s expert support.
Multi-Framework Documentation Requirements
Managing hundreds of suppliers across regions creates delays due to inconsistent formats, variable responsiveness, and decentralized tracking.
Certivo streamlines supplier coordination by:
Automating multilingual outreach and deadline reminders
Tracking submission status in real time
Standardizing document intake for fast review
Flagging unresponsive or high-risk vendors
Certivo streamlines supplier coordination by:
Automating multilingual outreach and deadline reminders
Tracking submission status in real time
Standardizing document intake for fast review
Flagging unresponsive or high-risk vendors
Re-certification Due to Component or Design Changes
Traditional methods require teams to manually audit the impact of each change across product lines, supplier records, and technical files — a time-consuming process prone to oversight.
Certivo enables structured change control and automated impact assessment by:
Mapping component-level dependencies to regulatory documentation across SKUs.
Flagging only the affected files or modules for re-certification, avoiding unnecessary updates.
Triggering targeted supplier outreach for updated declarations or supporting evidence.
Maintaining a full audit trail of document revisions, approvals, and rationale for partial or full recertification.
Certivo enables structured change control and automated impact assessment by:
Mapping component-level dependencies to regulatory documentation across SKUs.
Flagging only the affected files or modules for re-certification, avoiding unnecessary updates.
Triggering targeted supplier outreach for updated declarations or supporting evidence.
Maintaining a full audit trail of document revisions, approvals, and rationale for partial or full recertification.
Built-In Data Security and Recordkeeping Controls
Medical device compliance requires secure, long-term recordkeeping. Certivo includes:
Regulatory-grade hosting and encryption
Complete version control for all document changes and submissions
Role-based access controls to manage internal and third-party visibility
Retention compliance with MDR, FDA, and ISO standards
All documentation is stored with full traceability, ensuring readiness for audits, inspections, or legal inquiries.
Regulatory-grade hosting and encryption
Complete version control for all document changes and submissions
Role-based access controls to manage internal and third-party visibility
Retention compliance with MDR, FDA, and ISO standards
All documentation is stored with full traceability, ensuring readiness for audits, inspections, or legal inquiries.
Support for Change Control and Post-Market Surveillance
Medical device compliance doesn’t stop at product launch. Certivo extends support into post-market activities by:
Monitoring component-level changes that may require updated documentation or risk assessment
Providing historical traceability for complaint investigations and field corrective actions
Tracking response timelines and performance of suppliers involved in remediation
Ensuring surveillance obligations under MDR and FDA requirements are met with pre-configured data workflows
Monitoring component-level changes that may require updated documentation or risk assessment
Providing historical traceability for complaint investigations and field corrective actions
Tracking response timelines and performance of suppliers involved in remediation
Ensuring surveillance obligations under MDR and FDA requirements are met with pre-configured data workflows
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
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
Certivo Addresses Key Challenges in Medical Device Compliance
Overcome regulatory obstacles with Certivo’s expert support.
Multi-Framework Documentation Requirements
Certivo streamlines supplier coordination by:
Automating multilingual outreach and deadline reminders
Tracking submission status in real time
Standardizing document intake for fast review
Flagging unresponsive or high-risk vendors
Re-certification Due to Component or Design Changes
Certivo enables structured change control and automated impact assessment by:
Mapping component-level dependencies to regulatory documentation across SKUs.
Flagging only the affected files or modules for re-certification, avoiding unnecessary updates.
Triggering targeted supplier outreach for updated declarations or supporting evidence.
Maintaining a full audit trail of document revisions, approvals, and rationale for partial or full recertification.
Built-In Data Security and Recordkeeping Controls
Regulatory-grade hosting and encryption
Complete version control for all document changes and submissions
Role-based access controls to manage internal and third-party visibility
Retention compliance with MDR, FDA, and ISO standards
All documentation is stored with full traceability, ensuring readiness for audits, inspections, or legal inquiries.
Support for Change Control and Post-Market Surveillance
Monitoring component-level changes that may require updated documentation or risk assessment
Providing historical traceability for complaint investigations and field corrective actions
Tracking response timelines and performance of suppliers involved in remediation
Ensuring surveillance obligations under MDR and FDA requirements are met with pre-configured data workflows