Optimal Product Usability Suite
A cloud-based human factors engineering (HFE) platform that leverages training, tools, templates and regulatory guidance to help stay ahead in HFE activities.
Optimal Product Usability Suite (OPUS)
Emergo by UL’s human factors software platform providing training, templates, tools, and other resources to accelerate medical device time to market.
Smart Builder
A module within the Regulatory Affairs Management Suite (RAMS) designed to simplify medical device regulatory documentation, compliance, and registration dossiers for global markets such as Europe and Latin America.
RAMS Smart Builder
Software tool that walks you through regulatory documentation for Brazil’s Registro Route, Mexico Equivalency and more.
medical regulatory
Custom Regulatory Pathway Reports providing market access strategy and regulatory requirements for medical devices in smaller international markets across Latin America, Southeast Asia, Africa, and the Middle East.
Medical Device Regulatory Intelligence
Regulatory intelligence software providing access to processes and global market access help for medical device sellers.
European Authorized Representative
Professional European Authorized Representative (EC REP) services for medical device and IVD companies without a physical location within the EU, acting as a liaison with national competent authorities.
European Authorized Representative for Medical Device and IVD Companies
Professional European Authorized Representative (EC REP) services acting on behalf of non-EU medical device and IVD manufacturers.
US FDA
Comprehensive FDA regulatory consulting services for medical device and IVD manufacturers seeking market authorization and compliance in the United States.
US FDA Medical Device Classification
Consulting services to determine the correct regulatory classification for medical devices.
US FDA 510(k) Consulting for Medical Devices and IVDs
Expert consulting services for preparing and submitting 510(k) premarket notifications to the US FDA.
US FDA Electronic Medical Device Report (eMDR) Adverse Event Reporting for Medical Device Companies
Consulting and reporting support for electronic medical device adverse event reporting to the US FDA.
US FDA Agent Representation for Medical Device and IVD Companies
US agent representation services for international medical device and IVD manufacturers marketing products in the United States.
US FDA Form 483 and Warning Letter Analysis, Response, and Recovery
Expert assistance and consulting for analyzing, responding to, and recovering from FDA Form 483 observations and Warning Letters.
EU MDR
Specialized regulatory compliance consulting service addressing EU MDR requirements tailored for cosmetic and aesthetic products.
EU MDR Classification of Medical Devices
Learn the EU MDR classification of medical devices and deepen your understanding of the European CE marking regulatory...
European CE
Comprehensive consulting service to help medical device and IVD companies prepare Technical Documentation and obtain CE Marking under EU MDR 2017/745 and IVDR 2017/746.
European CE Marking Strategy for Medical Devices
Regulatory consulting service providing market entry and CE marking strategies for medical device companies entering the European market.
Software Development Lifecycle
Consulting and assessment services for medical device manufacturers to align software development lifecycles with international standards such as IEC 62304 and IEC 82304.
Software Development Lifecycle Training
Training service introducing IEC 62304 and IEC 82304 standards for medical device software development, risk management, and regulatory compliance.
Advanced Human Factors Engineering Report Writing
A 3-hour training course focused on how to write an accurate, complete and compelling HFE report for FDA submissions.
Advanced Human Factors Engineering Report Writing For FDA Submissions
This course will take someone who is already familiar with writing an HFE report to the next level.
ISO 13485 Consulting and Implementation for Medical Device Manufacturers
Consulting and implementation support for ISO 13485 quality management systems.
ISO 13485:2016 Consulting and Gap Analysis
Consulting and gap analysis services for implementing and maintaining ISO 13485:2016 quality management systems.
iso risk management consulting
Consulting services to help medical device companies establish, document, and maintain a systematic risk management process compliant with ISO 14971.
ISO 14971 Risk Management Consulting for Medical Device Companies
Consulting services to help medical device companies comply with ISO 14971 risk management standards.
Human factors engineering project scope tool
Complimentary tool to generate an HFE scope description for different types of projects such as product changes or IEC 62366 requirements.
Human factors test validation calculator
Complimentary tool to help define the scope and timeline for an HF validation test.
FDA QSR
Independent internal audits, gap analysis, supplier audits, pre-inspection audits, and mock audits to determine quality system compliance for medical device and IVD manufacturers.
FDA QSR Consulting (21 CFR 820) for Medical Device Manufacturers
FDA QSR consulting for medical device and IVD companies to help support successful 21 CFR Part 820 compliance.
FDA QSR Audits for Medical Device and IVD Companies
Auditing services for FDA Quality System Regulation compliance for medical device and IVD companies.
RAMS® RA/QA software
Regulatory Affairs and Quality Assurance software platform.
RAMS®
A platform of digital products to improve, simplify and automate RA/QA activities.
RAMS Product Classification
Regulatory intelligence tool for seamless medical device and IVD product classification, helping companies determine or verify device classification and regulatory pathways within minutes.
Emergo Pro
A bundling option for the RAMS platform including core regulatory tools for up to 5 licensed users.
OPUS
Emergo by UL’s new cloud-based human factors engineering (HFE) platform, Optimal Product Usability Suite (OPUS), leverages training, tools, templates and regulatory guidance to help you stay ahead in your HFE activities.
RAMS Regulatory Watch
A module within the Regulatory Affairs Management Suite that provides customized email notifications, expert insights, and intuitive filtering to track global medical device regulatory changes and guidance documents.
RAMS Registration Tracker
A cloud-based medical device registration and certification tracking software designed to automate critical elements of medical device registrations and prevent missed renewals.
Medical device EU authorized representative services
Authorized representative services to represent medical device companies in Europe and communicate with Competent Authorities.
Global Medical Device & IVD Registration Consulting
Consulting services to help medical device and IVD companies register their products in over 20 countries, managing premarket technical and clinical submission requirements.
European Union Medical Device Vigilance Reporting Services
Professional consulting and representation services assisting medical device and IVD manufacturers with EU vigilance reporting, post-market surveillance, serious incident reporting, and Field Safety Corrective Actions (FSCAs).
Medical Device Post-Market Surveillance Consulting
Global post-market vigilance support and consulting services for medical device and IVD companies, helping maintain compliance after devices go to market.
GreenLight Guru
Cloud-based quality management software optimized for the unique challenges and strict requirements of MedTech, featuring built-in controls for 21 CFR Part 820 and ISO 13485:2016.
Human Factors Research & Design Consulting
Consulting services provided by a team of experts to empower the development of medical products with safer, more effective, and superior user experiences, aligning with US FDA and global human factors engineering (HFE) standards.
Short Term or Part-time Medical Device QA/RA Outsourcing
Emergo provides short term quality assurance and regulatory affairs outsourcing for assistance with medical device registrations, QMS compliance, vigilance reporting and more.
Local Authorized Representative for Medical Device Manufacturers
Authorized representative services acting as a liaison between medical device manufacturers and local regulatory authorities.
EU IVDR Compliance Training for In Vitro Diagnostic Manufacturers
Compliance training services for in vitro diagnostic manufacturers navigating the EU IVDR.
Medical Device Market Access Consulting
Comprehensive consulting services to help medical device and IVD companies with regulatory compliance, market entry, and product registration across more than 20 countries.
Notified Body Support Services
Professional consulting and support services to assist medical device manufacturers with notified body selection, application submission, and regulatory compliance under the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
Medical Device Early Stage Design Consulting
Expert early-stage consulting services for medical device development, leveraging research, human factors, design, and regulatory expectations.
ComplianceWire
A web-based learning management system designed specifically for highly regulated industries to create and automate compliance training programs.
IVDD to IVDR Gap Analysis Services
Gap analysis consulting service assisting in the transition from IVDD to IVDR regulations for in-vitro diagnostic devices.
Clinical Evaluation Reports (CER) Services
Consulting and expert support services to help medical device manufacturers prepare and maintain fully compliant Clinical Evaluation Reports (CER) under Revision 4 and the European Medical Device Regulation (MDR 2017/745).
Writing Human Factors Engineering Reports For Regulatory Submissions
Learn how to write human factors engineering reports for regulatory submissions.
Intro to Human Factors Engineering for Medical Devices
Understand how HFE's user-centered design process supports the development of safer medical devices.
Known Problems Analysis Course
A 30-minute training course explaining how to conduct a known problems analysis (KPA) to discover previous errors and eliminate use error vulnerabilities in new products.
QMS Compliance for Startup Medical Device Companies
Consulting and implementation services for medical device and IVD startup companies to establish a partial pre-production quality management system compliant with US FDA QSR and ISO 13485.
Regulatory Due Diligence Service
Emergo by UL's Regulatory Due Diligence service assesses the current state of regulatory compliance of medical devices involved in mergers and acquisitions to identify discrepancies, gaps, and minimize post-transaction risks.
ISO 13845 Audit and Training Services for Medical Device Companies
Audit and training services focused on quality management standards for medical device companies.
Medical Device UDI (Unique Device Identification) Consulting and Training
Consulting and training services for Unique Device Identification implementation and regulatory compliance.
Usability Testing Training Course
Training course focused on usability testing methodologies for medical devices.
FDA Q-Sub Consulting and Pre-Sub Guidance for Medical Devices
Consulting services to guide medical device and IVD manufacturers through the US FDA Q-Submission and Pre-Submission process.
European Post-market Clinical Follow-up Studies (PMCF) for Medical Devices
Emergo assists medical device manufacturers with post-market clinical follow-up (PMCF) studies, investigations, clinical...
Risk Analysis Training For Medical Device Companies
Risk analysis training tailored for medical device companies.
European IVDR Consulting and CE Marking Services for IVDs
We help prepare CE marking submissions for IVD devices in compliance with the European IVDR, including support for IVD...
Residual Risk Analysis Training
Gain insight into how people perceive risk, residual risk analysis and its use in medical device development.
M&A Regulatory Due Diligence Services for Medical Devices
Regulatory compliance expertise seamlessly integrated into your M&A strategy, facilitating smooth market transitions.
Obtaining a Medical Device CFG (Certificate to Foreign Government) from FDA
Assistance and support for obtaining Certificates to Foreign Government from the FDA.
Brazil GMP (B-GMP) Quality System Compliance
Quality system compliance consulting services for Brazilian Good Manufacturing Practices (B-GMP).
RCA Wizard
Premium root cause analysis tool that guides you through the RCA process to identify potential root causes for usability test findings using a library of hundreds of root cause write-ups.
Root Cause Analysis (RCA) Online Training
Learn how Root Cause Analysis (RCA) is conducted to discover why problems occurred, and potentially mitigate such problems.
Advanced Residual Risk Analysis
This course will take someone who is already familiar with residual risk analysis to the next level.
Advanced Root Cause Analysis - Online Course
This course will take someone who is already familiar with root cause analysis to the next level.
Certificate of Free Sale (CFS) for Medical Device Exports
Emergo helps medical device companies secure Certificate of Free Sale (CFS) for medical device exports to countries...
Medical Device Usability Score (MDUS)
Questionnaire-based tool to evaluate your product and identify improvement opportunities.
Due Diligence Services for Mergers and Acquisitions
Our due diligence services help medical device companies navigate complex regulatory requirements to avoid...
Safety Label Quick Guide
Complimentary tool to create effective labels and messages that convey important safety information on a device, package, or instructions.
Touch target size accessibility tool
Tool to calculate recommended touch target dimensions based on screen size and HFE standards to reduce selection errors.