Medical Device Compliance, Without the Delays
Medical Device Compliance, Without the Delays
Automate, Streamline and Simplify Compliance Management
Managing compliance for environmentally sensitive biotech products is high-stakes—one missing document or delayed supplier response can derail your product timeline by months.
Certivo offers AI-powered tools that help environmental compliance leaders like you reduce friction in supplier onboarding and certification management—so you can move faster, with confidence.
Managing compliance for environmentally sensitive biotech products is high-stakes—one missing document or delayed supplier response can derail your product timeline by months.
Certivo offers AI-powered tools that help environmental compliance leaders like you reduce friction in supplier onboarding and certification management—so you can move faster, with confidence.
Managing compliance for environmentally sensitive biotech products is high-stakes—one missing document or delayed supplier response can derail your product timeline by months.
Certivo offers AI-powered tools that help environmental compliance leaders like you reduce friction in supplier onboarding and certification management—so you can move faster, with confidence.
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
Constantly Evolving Regulatory RequirementsYou’re navigating multiple frameworks:
Constantly Evolving Regulatory RequirementsYou’re navigating multiple frameworks:
ELV
IMDS
RoHS
TSCA
Prop 65
Conflict Minerals and cobalt traceability
OEM and country-specific document formats
IAFT 16949
ISO 26262
Quality and safety frameworks
Customer-specific flowdowns
Certivo keeps track of all of them — automatically monitoring changes, highlighting affected products, and alerting your team with clear next steps.
Constantly Evolving Regulatory RequirementsYou’re navigating multiple frameworks:
Constantly Evolving Regulatory RequirementsYou’re navigating multiple frameworks:
ELV
IMDS
RoHS
TSCA
Prop 65
Conflict Minerals and cobalt traceability
OEM and country-specific document formats
IAFT 16949
ISO 26262
Quality and safety frameworks
Customer-specific flowdowns
Certivo keeps track of all of them — automatically monitoring changes, highlighting affected products, and alerting your team with clear next steps.
Constantly Evolving Regulatory RequirementsYou’re navigating multiple frameworks:
Constantly Evolving Regulatory RequirementsYou’re navigating multiple frameworks:
ELV
IMDS
RoHS
TSCA
Prop 65
Conflict Minerals and cobalt traceability
OEM and country-specific document formats
IAFT 16949
ISO 26262
Quality and safety frameworks
Customer-specific flowdowns
Certivo keeps track of all of them — automatically monitoring changes, highlighting affected products, and alerting your team with clear next steps.
Complex Product Portfolios with Custom Parts
With thousands of components across product lines—many of them tailored for specific scientific or regulatory use—Certivo helps you:
Step 1
Supplier Certificates
We assess your needs and identify AI solutions to streamline workflows and improve efficiency.
Step 2
Full Material Declarations (FMDs)
Our team builds intelligent automation systems tailored to your business processes.
Step 3
Safety Data Sheets (SDSs)
We smoothly integrate AI solutions into your existing infrastructure with minimal disruption.
Step 4
Country or customer-specific compliance forms and ISO 13485 documentation
We refine performance, analyze insights, and enhance automation for long-term growth.
Case Studies
Case Studies
Case Studies
See How Smart AI Automation Transforms Businesses
See how AI automation streamlines operations, boosts and drives growth.
Multi-Tier Supplier Complexity
Your compliance depends on documentation from hundreds of suppliers — often Tier 2 or Tier 3 — who aren’t always responsive with FDA 21 CFR part 820
Certivo drives:
Basic workflow automation
90% supplier response rates
Automated outreach and follow-up
Language translation and communication management
Centralized dashboards to track responsiveness by supplier and product
Basic workflow automation
What Certivo Unlocks for Medical Device Teams
Impact :
Basic workflow automation
Faster product launches and market access
Streamlined audits and inspections
Full traceability from material to finished device
Proactive regulatory alerts and updates
Time savings for RA/QA teams by 80–90%
Confidence in documentation during FDA, Notified Body, or internal reviews under FDA 21 CFR part 820
How Certivo Works With You
CORA, our intelligent compliance agent, helps you:
Collect supplier certifications with intelligent automation
Monitor frameworks like EU MDR Compliance, ISO 13485, RoHS, and REACH
Parse and organize documents into audit-ready formats
Flag at-risk parts and expired certs in real time
Centralized dashboards to track responsiveness by supplier and product
Built for How You Work
Whether your team uses Salesforce, Excel, or legacy systems—Certivo integrates or offers a seamless onboarding experience.
Upload BOMs, track part-level compliance
View documentation status across all regions
Automatically translate and interpret supplier inputs
AI-powered insights to reduce re-certifying cycles
Multi-Tier Supplier Complexity
Your compliance depends on documentation from hundreds of suppliers — often Tier 2 or Tier 3 — who aren’t always responsive with FDA 21 CFR part 820
Certivo drives:
Basic workflow automation
90% supplier response rates
Automated outreach and follow-up
Language translation and communication management
Centralized dashboards to track responsiveness by supplier and product
Basic workflow automation
What Certivo Unlocks for Medical Device Teams
Impact :
Basic workflow automation
Faster product launches and market access
Streamlined audits and inspections
Full traceability from material to finished device
Proactive regulatory alerts and updates
Time savings for RA/QA teams by 80–90%
Confidence in documentation during FDA, Notified Body, or internal reviews under FDA 21 CFR part 820
How Certivo Works With You
CORA, our intelligent compliance agent, helps you:
Collect supplier certifications with intelligent automation
Monitor frameworks like EU MDR Compliance, ISO 13485, RoHS, and REACH
Parse and organize documents into audit-ready formats
Flag at-risk parts and expired certs in real time
Centralized dashboards to track responsiveness by supplier and product
Built for How You Work
Whether your team uses Salesforce, Excel, or legacy systems—Certivo integrates or offers a seamless onboarding experience.
Upload BOMs, track part-level compliance
View documentation status across all regions
Automatically translate and interpret supplier inputs
AI-powered insights to reduce re-certifying cycles
Multi-Tier Supplier Complexity
Your compliance depends on documentation from hundreds of suppliers — often Tier 2 or Tier 3 — who aren’t always responsive with FDA 21 CFR part 820
Certivo drives:
Basic workflow automation
90% supplier response rates
Automated outreach and follow-up
Language translation and communication management
Centralized dashboards to track responsiveness by supplier and product
Basic workflow automation
What Certivo Unlocks for Medical Device Teams
Impact :
Basic workflow automation
Faster product launches and market access
Streamlined audits and inspections
Full traceability from material to finished device
Proactive regulatory alerts and updates
Time savings for RA/QA teams by 80–90%
Confidence in documentation during FDA, Notified Body, or internal reviews under FDA 21 CFR part 820
How Certivo Works With You
CORA, our intelligent compliance agent, helps you:
Collect supplier certifications with intelligent automation
Monitor frameworks like EU MDR Compliance, ISO 13485, RoHS, and REACH
Parse and organize documents into audit-ready formats
Flag at-risk parts and expired certs in real time
Centralized dashboards to track responsiveness by supplier and product
Built for How You Work
Whether your team uses Salesforce, Excel, or legacy systems—Certivo integrates or offers a seamless onboarding experience.
Upload BOMs, track part-level compliance
View documentation status across all regions
Automatically translate and interpret supplier inputs
AI-powered insights to reduce re-certifying cycles
Multi-Tier Supplier Complexity
Your compliance depends on documentation from hundreds of suppliers — often Tier 2 or Tier 3 — who aren’t always responsive with FDA 21 CFR part 820
Certivo drives:
Basic workflow automation
90% supplier response rates
Automated outreach and follow-up
Language translation and communication management
Centralized dashboards to track responsiveness by supplier and product
Basic workflow automation
What Certivo Unlocks for Medical Device Teams
Impact :
Basic workflow automation
Faster product launches and market access
Streamlined audits and inspections
Full traceability from material to finished device
Proactive regulatory alerts and updates
Time savings for RA/QA teams by 80–90%
Confidence in documentation during FDA, Notified Body, or internal reviews under FDA 21 CFR part 820
How Certivo Works With You
CORA, our intelligent compliance agent, helps you:
Collect supplier certifications with intelligent automation
Monitor frameworks like EU MDR Compliance, ISO 13485, RoHS, and REACH
Parse and organize documents into audit-ready formats
Flag at-risk parts and expired certs in real time
Centralized dashboards to track responsiveness by supplier and product
Built for How You Work
Whether your team uses Salesforce, Excel, or legacy systems—Certivo integrates or offers a seamless onboarding experience.
Upload BOMs, track part-level compliance
View documentation status across all regions
Automatically translate and interpret supplier inputs
AI-powered insights to reduce re-certifying cycles
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