U.S. FDA Selects ComplianceQuest QRC System to Modernize Enterprise QMS
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ComplianceQuest Medical Devices QMS Success Stories eBook
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18 Oct, 2026
Boston, MA
About
About ComplianceQuest
ComplianceQuest is the #1 AI-powered Quality, Risk, and Compliance (QRC) platform that connects Product, Quality, Manufacturing, People, Suppliers and Customers in a single system.
Built on Salesforce, the platform delivers end-to-end visibility, AI-driven intelligence, and enterprise-scale execution, enabling organizations to manage risk, ensure regulatory compliance, and turn quality into a driver of growth.
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Upcoming Events
Quality Management System for Clinical Trials: A Risk-based Approach
Checklist | October, 2021
Are You Sure, Your Medical Device Clinical Study Complies With GCP Principles?
Guidance Towards Preparation of Post Market Surveillance for Medical Devices (Part A)
Guidance Towards Preparation of Post Market Surveillance for Medical Device (Part B)
Suppliers Activities Impacting Manufacturer Regulatory Compliance (EU IVDR): in-vitro diagnostic
Suppliers Activities Impacting Manufacturer Regulatory Compliance (EU MDR): medical device
Comprehensive Guide for Establishing a Vigilance System
Vigilance Reporting and Monitoring (For EU Market)
Field Safety Corrective Action (FSCA) For Medtech Companies
Essential Responsibilities of Distributor(s) Under EU IVDR
Checklist | September, 2021
Importer(s)’ Obligations Under EU IVDR
Supplier Information and Approval Template (for new and existing supplier) for MedTech and Pharmaceutical Companies
Is Your Internal Communication Related to QMS (ISO 13485) Adequate?
Understanding the Medical Device Risk based Approach in a QMS
Plan your readiness with the PMPF Plan Template for Post-Market Performance Follow-Up of IVD devices and ensure full regulatory compliance.
A Ready-to-use PMPF Plan Template to Report the Post Market Performance Follow-Up (PMPF) for IVD devices.
A Reporting Template for IVD Device’s Clinical Performance Study
Conduct Efficient Performance Evaluation of Your IVD Devices with this Planning Framework
A Guided Approach to Clinical Performance Study for IVD Device’s – A Planning Template
Ensure Complete Reporting on Post Market Clinical Follow-up [PMCF] – A Reporting Template
Generate Comprehensive Performance Evaluation Report of your IVD Device(s)
How to Effectively Plan for Post Market Clinical Follow-up [PMCF] – A Planning Template
Are You Preparing for UKCA? Assess Your Preparedness for UKCA
Does your Medical Device Technical File Comply with MDR 2017/745 Requirements?
Checklist | August, 2021
Does your post-market surveillance (PMS) plan address the current regulatory requirements (IVDR)? [Checklist]
Preparing For General Safety & Performance Requirements [GSPR] Under The MDR – A Comprehensive Guide
Pharmaceutical CGMP Regulations with Quality System Part 3
Medical Device Software Lifecycle Processes Checklist (Part 2)
Medical Device Software Lifecycle Processes Checklist (Part 1)
Pharmaceutical Product Lifecycle Activities
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