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The only AI-powered Middle Office Platform that unifies PLM, QMS, EHS, and SRM into a single, intelligent solution
Product Lifecycle Management
Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Design Quality
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Complaints Management
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Document and Learning Management
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Quality Management
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
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Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
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The Ultimate Guide to Next-Generation Supplier Management [e-Book]
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Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
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ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
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20 May, 2025
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About ComplianceQuest
Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase quality, safety and efficiency as they bring their products from concept to customer success.
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In one of our earlier blogs, we wrote about the first step that is needed to build a robust QMS workflow for your medical device company. Even before we get started, the key is to understand the regulatory landscape. This includes understanding the finer nuances of the requirements of ISO 13485, FDA Software Validation, European Union’s MDR and IVDR, etc.
Once that is done, we need to design a robust, data-driven workflow for quality and compliance. In today’s day and age, it is a no-brainer to use quality as a key parameter to drive competitive advantage and not just try to meet compliance requirements.
In this blog, we share some best practices to design a quality and compliance workflow in the medical device industry.
An enterprise-wide Quality Management System like the cloud-based solution from ComplianceQuest can facilitate meeting the quality goals of the medical device manufacturing company. But, before choosing one, an organization must identify its quality goals based on the maturity level of the company. Based on that, it will have to establish a process that meets a few prerequisites.
Also, there should be an assessment of the status of the current quality practices and areas that need improvement. This will facilitate the development of the quality goal and designing an efficient but end-to-end quality process. The goals should be delineated as a quality policy and detailed in a quality manual elaborating the scope, procedures, guidelines and checklists for implementation and measures for continuous improvement.
The policy will delineate the procedures as required by the compliance standard, enabling effective planning, operations, monitoring and control.
Some of the metrics to measure success would be:
In order for your EQMS journey to be successful, there are two prerequisites:
Maintaining documents and records of every process and every revision is essential even for compliance needs. While it may seem like additional work, it is beneficial for the organization in the long run and so needs to be part of the process being designed.
Training to be able to follow the quality process at every level is essential for the organization to meet its quality goals. It is not only about having the requisite skills for the task at hand, but also for following the processes as laid down in the policy. A good EQMS will have a robust document management and training solution, one that will ensure a culture of quality spreads far and wide across the enterprise.Here’s a short checklist to make sure your EQMS journey starts off on the right note:
In this whitepaper, we share “A 7-Step Guide to Quality & Compliance for Medical Devices Companies” based on ComplianceQuest’s experience of serving 100+ customer customers in the medical device space.
Read it here: https://www.compliancequest.com/whitepaper/a-7-step-guide-to-quality-compliance-for-medical-devices-companies/
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