smarteeva

Smarteeva provides highly adaptable artificial intelligent post-market surveillance tools for the Medical Device industry.

[smarteeva @SmarteevaAI]

Filing an MDR takes minutes. Getting to the point where you can file takes much longer.

Before submission, someone reads the complaint, checks device history, decides reportability, fills the 3500A fields and gets sign-off. When that runs on spreadsheets and email, each step waits on the one before it.

The FDA gives you 30 calendar days from awareness, and 5 work days for some events. The clock keeps running while the spreadsheet waits.

Our blog on complaint intake walks through where those days go and how teams get them back.

Read the blog: https://t.co/xIxNfXuAUB

#PostMarketSurveillance #MedTech #MedicalDevices

[smarteeva @SmarteevaAI]

Book a demo 👇
https://t.co/5nSzf7kpnH

[smarteeva @SmarteevaAI]

35% of all medical device reports filed with the FDA go through Smarteeva.

That share comes from one early decision. Post-market quality is the product we build, so every release goes into complaints, adverse events, PSURs and recalls.

In Smarteeva, the complaint, the reportability decision and the eMDR sit in one record. Filing through ESG NextGen takes under 3 minutes.

If your MDRs still start with copy and paste, the demo link is in the first comment.

#PostMarketSurveillance #MedTech #MedicalDevices

[smarteeva @SmarteevaAI]

Most eQMS platforms started with document control and training. Complaints arrived later, as a module.

That holds up until post-market volume grows. Then complaints get exported to a spreadsheet for the PSUR, MDR fields get re-keyed, and recall acknowledgements get tracked by email.

This carousel sets what a typical post-market module covers next to what the work asks for. Swipe through and tell us in the comments where your current setup stops.

Tell us in the comments 👇

#QualityManagement #MedTech #MedicalDevices

[smarteeva @SmarteevaAI]

☑️ Intuitive receives CE mark for da Vinci 5 cardiac procedures. The latest CE mark covers certain coronary artery bypasses, as well as thoracoscopic cardiotomy procedures.

☑️ Abbott to update CardioMEMS to allow patients to track pulmonary artery pressure.

☑️ Edwards Lifesciences earns FDA approval for first-of-its-kind size-adjustable pediatric heart valve.

☑️ Abbott rolls out SimpleScreen colorectal cancer blood test developed by Freenome.

☑️ Truvian links with Siemens Healthineers to advance benchtop blood testing.

#InsightswithSmarteeva #Medtech #Pharma #Smarteeva #biotech #medtechtrends

[smarteeva @SmarteevaAI]

The full implementation answer is in our FAQ: https://t.co/f9mzFJ8Df2
https://t.co/f9mzFJ8Df2

[smarteeva @SmarteevaAI]

How long does it take to replace a post-market system? At Smarteeva, the standard implementation runs 12 weeks in four phases.

☑️ Weeks 1 to 3: we map your current complaint workflows, data structures and integration points.

☑️ Weeks 4 to 8: we configure the platform and migrate historical data with full integrity validation.

☑️ Weeks 9 to 10: Smarteeva runs alongside your current system, so your team can check accuracy before cutover.

☑️ Weeks 11 to 12: go-live and legacy decommission, with a dedicated support team for the first 30 days.

Regulatory operations keep running the whole way through.

#MedicalDevices #PostMarketSurveillance #QualityManagement

[smarteeva @SmarteevaAI]

Get the free ISO 14971 risk analysis template:
https://t.co/FHhjmCVufY

[smarteeva @SmarteevaAI]

Open most free ISO 14971 templates and you'll find a detection column.

ISO 14971 doesn't use one. The standard estimates risk from the severity of harm and the probability that harm occurs. Detection comes from automotive FMEA, and a high detection score can pull a risk rating down in a way an auditor may question.

We built a free template that follows the standard's own chain:

Hazard → sequence of events → hazardous situation → harm

Inside the workbook:

▶️ Five tabs, from document control to overall residual risk
▶️ Editable severity and probability scales with an acceptability matrix
▶️ Columns for verification, risk reduction as far as possible, and links back to complaint data
▶️ Five worked examples for a fictional infusion pump

Download link in the first comment.

Does your current risk template have a detection column?

#ISO14971 #RiskManagement #MedicalDevices #RegulatoryAffairs

[smarteeva @SmarteevaAI]

Smart Pulse #26 is out.

Our CEO was featured in Pharmaceutical Technology on why the risk file was never meant to be a once-a-year exercise. And our team at Dreamforce 2026, a free ISO 14971 template, and more!

Click on the link to read: https://t.co/RlkH6OJgHs

#MedTech #ISO14971
https://t.co/RlkH6OJgHs

[smarteeva @SmarteevaAI]

Download it:
https://t.co/FHhjmCVufY

[smarteeva @SmarteevaAI]

Most ISO 14971 risk files start the same way: a blank spreadsheet and a lot of copying from the last project.

We put together a free ISO 14971 risk management template so your team can skip that step. It gives you a structured place to document hazards, estimate risk, and record the controls you put in place.

Download it, adapt it to your device, and put the hours into the analysis itself.

Get the free template; link in the comments 👇

#ISO14971 #RiskManagement #MedicalDevices #MedTech #RegulatoryAffairs

[smarteeva @SmarteevaAI]

Ask your post-market surveillance vendor one question: can you generate the submission, or only store the data?

Weak answer: we store it; your team files it.
Strong answer: MDR, MIR and PSUR produced from the record.

Five more worth asking:
https://t.co/5VJ8RJpqIc

#MedTech #RegulatoryAffairs
https://t.co/5VJ8RJpqIc

[smarteeva @SmarteevaAI]

Every Dreamforce has one theme that quietly takes over the floor. This year it was agents doing real work.

Our team spent the week in San Francisco watching that play out across sessions, demos and Campground conversations. Less "here's what AI could do." More "here's what it's already doing."

That's a useful signal for us. Smarteeva runs natively on Salesforce, and post-market quality is full of the repetitive, high-stakes work agents are getting good at.

Good week. Plenty to take back.

#Dreamforce2026 #Salesforce #Agentforce #MedTech #RegulatoryAffairs

[smarteeva @SmarteevaAI]

Day 1 at RAPS Convergence 2026. We are at Booth #902 for the next three days!

If you handle complaints, adverse events, or recalls and you want a straight conversation about what automation actually covers, Booth #902 is the place to be. Fifteen minutes, no pitch deck.

📍 Charlotte Convention Center.

#RAPSConvergence #RAPS2026 #PostMarketSurveillance #RegulatoryAffairs #MedTech

[smarteeva @SmarteevaAI]

Tomorrow, Booth 902.

If your team still moves complaint data between systems by hand, or reconciles FDA and Health Canada submissions from two different records, that is the conversation we want to have at RAPS.

We'll walk you through how decision trees, automated submissions, and field-level audit trails work on one platform: fifteen minutes, no slides.

Charlotte Convention Center, 15 to 17 September.

#RAPSConvergence #PostMarketSurveillance #FDA #MedicalDevices #QualityManagement

[smarteeva @SmarteevaAI]

Five teams. One complaint. No shared system.

Quality, Regulatory, Customer Care, Product, and Risk each needed a different view of the same complaint data, with different access levels. Nothing was connecting them.

Here is how a SaMD manufacturer put all five on one platform, with submissions running to FDA and Health Canada from the same record.

Decision trees fire on intake. Regulatory submissions auto-populate from product registration. Every field-level change is audit-trailed.

Read the case study: https://t.co/0ooJjZo5uF

#PostMarketSurveillance #MedTech #FDA #SaMD #QualityManagement
https://t.co/6GK3R3sWqr

[smarteeva @SmarteevaAI]

Booth #902. Charlotte. 15 to 17 September.

We're exhibiting at RAPS Convergence 2026. Come and tell us where post-market surveillance is costing you time, and we'll show you what it looks like when complaints, adverse events, MDR filings, recalls, and risk sit in one Salesforce-native platform.

Jaime Castillo is at the booth all three days. Book a slot instead of hoping to catch us between sessions: https://t.co/a1shMju73w

#RAPSConvergence #RegulatoryAffairs #MedicalDevices

https://t.co/ocILMrKC4i

[smarteeva @SmarteevaAI]

We're exhibiting at RAPS Convergence 2026 in Charlotte, North Carolina, 15 to 17 September.

Find us at Booth #902. If you work in regulatory affairs or post-market quality, come and say hello.

Preconference workshops run 14 and 15 September.

#RAPSConvergence #RegulatoryAffairs #MedTech #QualityManagement