Medical Device Compliance, Without the Delays
Medical Device Compliance, Without the Delays
Automate, Streamline and Simplify Compliance Management
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.
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
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:
REACH
CLP
SVHC
Microplastics
PPWR & Recyclability
CMR Substances
IFRA & Allergens
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:
REACH
CLP
SVHC
Microplastics
PPWR & Recyclability
CMR Substances
IFRA & Allergens
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:
REACH
CLP
SVHC
Microplastics
PPWR & Recyclability
CMR Substances
IFRA & Allergens
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
Removing Compliance Barriers for Automotive Leaders
Overcome regulatory obstacles with Certivo’s expert support.
BOM Complexity Increases with Every Platform
Modern vehicles involve:
30,000+ components
Dozens of Tier 2 and Tier 3 suppliers
Rapid engineering changes and platform variants
Certivo brings structure to this complexity:
Tracks compliance at the part, product line, and supplier level
Identifies missing or outdated certifications
Organizes FMDs, SDSs, CoCs, and more in a single audit-ready platform
Supports IMDS reporting and integration
Stay Ahead of RFQs, Audits & SOP Milestones
Delays in documentation cause costly consequences:
Missed production start dates
Failed PPAP submissions
Rejected RFQs
Lost OEM trust or programs
Certivo helps your team deliver:
Export-ready documentation aligned to each OEM’s needs
Faster responses to supplier or customer audits
Structured data to support requalification and design changes
Executive Dashboards to Track Performance
As a business leader, you need clarity and measurable ROI.
Certivo provides:
Compliance coverage by supplier, platform, and product
Response rates and cycle times
Risk visibility across your supplier network
Exportable reports for leadership, boards, or customers
You get real-time data to track progress, justify investment, and drive accountability across teams.
Scale Supplier Engagement
Certivo automates supplier communication:
Sends multilingual requests and reminders
Tracks open, pending, and complete documentation
Handles validation, classification, and expiration tracking
Supports suppliers who don’t use BOMcheck or internal portals
Even with hundreds of suppliers, your team stays in control.
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.
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.
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
Case Studies
Case Studies
Case Studies
See How Smart AI Automation Transforms Businesses
See how AI automation streamlines operations, boosts and drives growth.
Powered by CORA
CORA is Certivo’s intelligent compliance engine, built to interpret and structure regulatory data across jurisdictions. CORA:
Validates supplier-submitted documentation in various formats
Structures data by part, product line, or use case
Tracks regulatory changes and flags affected SKUs
Supports multilingual communication with suppliers
Generates complete, export-ready audit files
What Certivo Enables for Medical Device Teams
Centralized document control for MDR, FDA, and ISO submissions
Real-time alerts for expiring or missing supplier declarations
Faster supplier coordination across multiple geographies and formats
Structured documentation output for notified bodies, audits, and submissions
Significant reduction in manual workload through automation and intelligent validation
Consistent, traceable compliance records across products and markets
Integration with Quality and PLM Systems
Certivo is designed to complement existing infrastructure.
Integrates seamlessly via API to sync compliance data across systems
Eliminates duplicate data entry and manual reconciliation
Ensures that part status, supplier records, and declarations are current across the entire digital thread
Enables cross-functional traceability from engineering change to regulatory submission
Built for Complex Product Portfolios
Certivo supports medical device organizations managing:
Class I, II, and III device portfolios
Cross-border distribution with regional documentation needs
Post-market surveillance and technical file maintenance
Multi-supplier assembly workflows with component-level traceability
Powered by CORA
CORA is Certivo’s intelligent compliance engine, built to interpret and structure regulatory data across jurisdictions. CORA:
Validates supplier-submitted documentation in various formats
Structures data by part, product line, or use case
Tracks regulatory changes and flags affected SKUs
Supports multilingual communication with suppliers
Generates complete, export-ready audit files
What Certivo Enables for Medical Device Teams
Centralized document control for MDR, FDA, and ISO submissions
Real-time alerts for expiring or missing supplier declarations
Faster supplier coordination across multiple geographies and formats
Structured documentation output for notified bodies, audits, and submissions
Significant reduction in manual workload through automation and intelligent validation
Consistent, traceable compliance records across products and markets
Integration with Quality and PLM Systems
Certivo is designed to complement existing infrastructure.
Integrates seamlessly via API to sync compliance data across systems
Eliminates duplicate data entry and manual reconciliation
Ensures that part status, supplier records, and declarations are current across the entire digital thread
Enables cross-functional traceability from engineering change to regulatory submission
Built for Complex Product Portfolios
Certivo supports medical device organizations managing:
Class I, II, and III device portfolios
Cross-border distribution with regional documentation needs
Post-market surveillance and technical file maintenance
Multi-supplier assembly workflows with component-level traceability
Powered by CORA
CORA is Certivo’s intelligent compliance engine, built to interpret and structure regulatory data across jurisdictions. CORA:
Validates supplier-submitted documentation in various formats
Structures data by part, product line, or use case
Tracks regulatory changes and flags affected SKUs
Supports multilingual communication with suppliers
Generates complete, export-ready audit files
What Certivo Enables for Medical Device Teams
Centralized document control for MDR, FDA, and ISO submissions
Real-time alerts for expiring or missing supplier declarations
Faster supplier coordination across multiple geographies and formats
Structured documentation output for notified bodies, audits, and submissions
Significant reduction in manual workload through automation and intelligent validation
Consistent, traceable compliance records across products and markets
Integration with Quality and PLM Systems
Certivo is designed to complement existing infrastructure.
Integrates seamlessly via API to sync compliance data across systems
Eliminates duplicate data entry and manual reconciliation
Ensures that part status, supplier records, and declarations are current across the entire digital thread
Enables cross-functional traceability from engineering change to regulatory submission
Built for Complex Product Portfolios
Certivo supports medical device organizations managing:
Class I, II, and III device portfolios
Cross-border distribution with regional documentation needs
Post-market surveillance and technical file maintenance
Multi-supplier assembly workflows with component-level traceability
Powered by CORA
CORA is Certivo’s intelligent compliance engine, built to interpret and structure regulatory data across jurisdictions. CORA:
Validates supplier-submitted documentation in various formats
Structures data by part, product line, or use case
Tracks regulatory changes and flags affected SKUs
Supports multilingual communication with suppliers
Generates complete, export-ready audit files
What Certivo Enables for Medical Device Teams
Centralized document control for MDR, FDA, and ISO submissions
Real-time alerts for expiring or missing supplier declarations
Faster supplier coordination across multiple geographies and formats
Structured documentation output for notified bodies, audits, and submissions
Significant reduction in manual workload through automation and intelligent validation
Consistent, traceable compliance records across products and markets
Integration with Quality and PLM Systems
Certivo is designed to complement existing infrastructure.
Integrates seamlessly via API to sync compliance data across systems
Eliminates duplicate data entry and manual reconciliation
Ensures that part status, supplier records, and declarations are current across the entire digital thread
Enables cross-functional traceability from engineering change to regulatory submission
Built for Complex Product Portfolios
Certivo supports medical device organizations managing:
Class I, II, and III device portfolios
Cross-border distribution with regional documentation needs
Post-market surveillance and technical file maintenance
Multi-supplier assembly workflows with component-level traceability
DRAG TO EXPLORE
DRAG TO EXPLORE
"AI-driven forecasting cut inventory waste by 40% for TrailForge"
TrailForge, a suitcase brand, faced stock issues and inefficiencies. Our AI forecasting optimized inventory and production cycles, helping them save costs and deliver faster.
Impact :
40% Less Inventory Waste
35% Faster Production
20% More Accurate Forecasting
25% Faster Fulfillment
"AI-driven forecasting cut inventory waste by 40% for TrailForge"
TrailForge, a suitcase brand, faced stock issues and inefficiencies. Our AI forecasting optimized inventory and production cycles, helping them save costs and deliver faster.
Impact :
40% Less Inventory Waste
35% Faster Production
20% More Accurate Forecasting
25% Faster Fulfillment
"AI-powered workflows reduced error rate by 80% in daily operations"
MedixChain, a healthcare logistics company, was dealing with frequent data errors and delays. We introduced AI validation and live tracking to improve accuracy and speed across their supply chain.
Impact :
80% Error reduction
90% Accuracy in Data Logs
30% Faster Delivery
60+ Hours Saved
"AI-powered workflows reduced error rate by 80% in daily operations"
MedixChain, a healthcare logistics company, was dealing with frequent data errors and delays. We introduced AI validation and live tracking to improve accuracy and speed across their supply chain.
Impact :
80% Error reduction
90% Accuracy in Data Logs
30% Faster Delivery
60+ Hours Saved
"AI integration helped ScaleByte close 3x more deals in less time"
ScaleByte’s sales team struggled with follow-up delays. Our AI sales assistant automated outreach, lead scoring, and CRM updates—resulting in faster responses and more closed deals.
Impact :
3x More Deals
40% Faster Responses
95% Lead Accuracy
CRM Fully Synced
"AI integration helped ScaleByte close 3x more deals in less time"
ScaleByte’s sales team struggled with follow-up delays. Our AI sales assistant automated outreach, lead scoring, and CRM updates—resulting in faster responses and more closed deals.
Impact :
3x More Deals
40% Faster Responses
95% Lead Accuracy
CRM Fully Synced
"Automating 50% of operations saved 20% in costs in 2 months"
FinSolve, a financial services firm, was overloaded with repetitive tasks. By automating workflows and integrating data systems, they streamlined operations and significantly reduced overhead.
Impact :
50% Operations Automated
20% Cost Reduction
70+ Hours Saved/Month
2x Faster Client Onboarding
"Automating 50% of operations saved 20% in costs in 2 months"
FinSolve, a financial services firm, was overloaded with repetitive tasks. By automating workflows and integrating data systems, they streamlined operations and significantly reduced overhead.
Impact :
50% Operations Automated
20% Cost Reduction
70+ Hours Saved/Month
2x Faster Client Onboarding