Complaint Handling Software Built for Medical Devices,
and Beyond.
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and FHR using Salesforce and MuleSoft.
Our Partners in Healthcare






Digital Health & Interoperability
Automated Clinical Data Retrieval
Once a patient confirms an appointment in Salesforce Health Cloud, an automated system is triggered to retrieve the patient’s complete clinical history from connected Health Information Exchanges
Real-Time EHR Integration
The system gathers electronic health records (EHRs) from multiple sources and formats, ensuring seamless access to up-to-date and interoperable patient data.

Richard Ngo
Healthcare & Salesforce Practice Lead
Context-Aware Data Presentation
Key clinical insights, medical trends, and appointment-relevant data are intelligently organized and displayed, helping providers make data-driven decisions faster.
Streamlined Physician Workflow
Doctors save valuable time by avoiding manual record reviews across multiple EMRs (Electronic Medical Records), improving both clinical efficiency and patient care quality.
Use Cases
A specialist needs payer approval for a high-cost imaging/procedure. Payer utilizes X12 278 transactions and FHIR-based prior auth APIs for quick insurance approval. This workflow reduces delays, improves patient satisfaction, reduces administrative burden, and enhances payer-provider collaboration.
A provider monitors patients with chronic conditions (diabetes, hypertension, etc.) using a wearable device. This device transmits data back to the provider's system using FHIR APIs and Bluetooth/IoT protocols. Downstream EHR systems can integrate this data for risk scoring, alerts, and clinical decision support.
After a new patient provides all the personal information, the staff retrieve all possible clinical information via an EMR that is connected to all major health exchanges. However, it is usually daunting to review all the medical records from different EMR/EHR systems. With the right tools, the provider may only want to see abnormal trends, medical history, etc., to have a more precise initial assessment as a baseline for treatment.
A patient moves from one primary care provider to another provider group in another state. With interoperability, the new provider will be able to enroll the patient and seamlessly transfer the patient's medical history, prescriptions, medications, lab results, allergies, and imaging via connectivity to health exchanges (Carequality, Commonwell, eHealth Exchange, etc.). This alone saves the new provider and staff a lot of time, effort, and may even reduce duplicate testing and ensure continuity of care.
A specialist needs payer approval for a high-cost imaging/procedure. Payer utilizes X12 278 transactions and FHIR-based prior auth APIs for quick insurance approval. This workflow reduces delays, improves patient satisfaction, reduces administrative burden, and enhances payer-provider collaboration.
A provider monitors patients with chronic conditions (diabetes, hypertension, etc.) using a wearable device. This device transmits data back to the provider's system using FHIR APIs and Bluetooth/IoT protocols. Downstream EHR systems can integrate this data for risk scoring, alerts, and clinical decision support.
After a new patient provides all the personal information, the staff retrieve all possible clinical information via an EMR that is connected to all major health exchanges. However, it is usually daunting to review all the medical records from different EMR/EHR systems. With the right tools, the provider may only want to see abnormal trends, medical history, etc., to have a more precise initial assessment as a baseline for treatment.
Our Solution
Challenge
Unified platform for complaint management.
Extended resolution times affecting patient satisfaction
Customizable workflows to fit organizational needs.
Disparate systems causing data inconsistencies.
Comprehensive analytics for informed decision making.
Challenges in meeting compliance requirements.
Medical Device Manufacturers
Stay Audit Ready 100% Patient-Centered with Every Complaint
- Automate FDA 21 CFR Part 820 complaint workflows
- Align with ISO 13485 for CAPA and traceability.
- Centralize responses across devices, SKUs, and geographies
- Enable SLA tracking and root cause documentation
- Real-time integration with Salesforce Health Cloud or Service Cloud
Our Solution
Challenge
Automated workflows tailored for medical devices.
Audit trail related to the complaint
Integration with existing systems for seamless data flow.
Risk of non-compliance with regulatory standards.
Real-time tracking and reporting capabilities.
Siloed systems hindering efficient resolution.
Why PlektonLabs?
We are built for Interoperability and trusted by healthcare innovators. As a Salesforce development partner, we specialize in healthcare interoperability. Our expertise lies in consistently demonstrating deep domain knowledge, technical excellence, regulatory understanding, and strong ecosystem integration capabilities.
1. Proven Experience with Healthcare-Specific Salesforce Clouds
- Expertise in Health Cloud, Service Cloud, and Marketing Cloud, configured for care coordination, patient engagement, and provider workflows.
- Customizes Clinical Data Models (CDM) and integrates FHIR-compatible APIs.
- Implements OmniStudio or Experience Cloud portals tailored for providers, payers, or patients.
2. Interoperability Integration with External Health Systems
Seamlessly connects to:
- Health Information Exchanges (HIEs) – e.g., CommonWell, Carequality, eHealth Exchange.
- EHRs (Epic, Cerner, athenahealth, etc.) using FHIR, HL7, CCD, X12, or custom APIs.
- Lab systems, pharmacies, and payers via standards like X12 270/271, 835/837, and LIS integrations.
3. Mastery of Interoperability Standards & Regulations
Deep understanding of:
- 21st Century Cures Act
- ONC & CMS rules on data blocking and patient access
- HIPAA, HITECH, and GDPR
- Ensures compliance with both US and global health data privacy and interoperability laws.
4. End-to-End Integration Using Mulesoft & HL7-FHIR APIs
- Leverages MuleSoft (a Salesforce company) to orchestrate data across:
- Salesforce, EHRs, Health Exchanges, and Third-party platforms.
- Builds reusable API-led architecture with standardized FHIR resources and error-handling.
5. Real-World Implementations with Outcomes
Can demonstrate:
Decreased patient onboarding time
Improved care coordination across systems
Automation of referral intake, prior authorization, or clinical data reconciliation
Backed by case studies, client testimonials, and audit-passed deployments.
Our Services
Major health exchanges. Seamless data flow. Accurate information at the right time. Actionable.
- Connect major health exchanges to EMRs via Salesforce
- Retrieve specific patient medical information efficiently
- Share lab test results via MuleSoft integration to any doctor
- Save time by syncing records across all systems
- Reduce risk through fewer manual data handling errors
- Meet security requirements with HIPAA-compliant data connections
Our Solution
Challenge
Interoperable systems tailored for digital health.
Manual data searches in health exchanges cause critical delays.
Integrated with major health exchanges, Salesforce speeds up data access.
Delays in data results, delays in care.
End-to-end visibility and coordination with adapted integration system.
Operational blind spots due to non-integrated systems.
Digital Health FAQs
What is Digital Health?
Digital health encompasses the use of technology to improve health outcomes. This includes mobile health apps, wearable devices, telemedicine, electronic health records (EHRs), artificial intelligence (AI), and remote patient monitoring (RPM).
How is patient data kept secure and HIPAA-compliant?
Digital health solutions must implement encryption, access control, audit trails, and comply with HIPAA (US and other regulations if we/customer were to use the platform outside US) to protect patient health information (PHI).
How do digital health platforms integrate with existing EHR systems?
Modern platforms utilize FHIR, HL7, CCD, and APIs for seamless EHR integration (Epic, Cerner, Allscripts). Salesforce, via MuleSoft Anypoint Platform, connects to major health exchanges (Carequality, eHealth Exchange) using FHIR-based APIs for real-time integration with EHRs, claims systems, and data sources.
What is a Health Information Exchange (HIE)?
A Health Information Exchange (HIE) is a platform or network that allows healthcare organizations to electronically share clinical information to support care coordination, quality, and outcomes.
What measurable benefits do digital health solutions offer providers and patients?
Key benefits include:
- Improved access to care (e.g., telehealth)
- Enhanced patient engagement: easier access, engagement, chronic care support
- Better chronic disease management
- Reduced hospital readmissions
- Streamlined workflows for clinicians
- For providers: Workflow efficiency, reduced readmissions, and data-driven decision-making
Let's Map Out Your Next Move
Built for Healthcare,
Backed by Salesforce & MuleSoft.






Our solution is deployable in Salesforce Health Cloud, Service Cloud, or integrated into existing infrastructure with MuleSoft accelerators.
Consistent Value, End-to-end
Every touchpoint isn’t just created but designed to move your business forward with clarity, speed, and purpose.
Does PlektonLab offer Health Cloud Integration for clinical and operational workflows?
Yes. We build customer workflows between EHRs, patient engagement platforms, and Salesforce Health Cloud to drive case management, care plans, and longitudinal records.
How do our solutions support care coordination within Salesforce?
We create unified data layers that connect clinical, operational, and engagement systems, enabling care teams to collaborate around accurate, real-time data in Salesforce.
Can you integrate Salesforce with my existing patient portals, or telehealth platforms?
Definitely. We create APIs and connectors that bridge Salesforce with tools like Epic, Center, Athenahealth, or custom patient portals, improving continuity and reducing toggling.
What level of support do you provide post-integration?
We offer continuous monitoring, optimization, and compliance updates, ensuring that your Salesforce + EHR + device stack evolves with your needs and regulations.
Can PlektonLabs help us scale our interoperability strategy?
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