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MedQdoc is tailor-made for the MedTech industry

 
 

A pre-validated eQMS with extensive built-in functionalities designed to accelerate compliance and help bring safer products to market faster.

Developed by regulatory and compliance experts, our eQMS is a simpler, smarter and more streamlined quality management system, helping medical device companies comply with ISO 13485, ISO 14971, QSR, MDR and IVDR.

Discover how MedQdoc’s all-encompassing features and functionalities can help your medical device company save time, remain compliant and deliver high-quality products

MedTech Industry

Document
control

MedTech Document Control

Keep track of documents effortlessly with our intuitive, streamlined and automated document control system.

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Technical
documentation

MedQdoc training management icon — track employee training, competence and QMS awareness.

Develop and organize your key technical product documents in clous location using predefined document structures and templates.

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Training
management

MedQdoc training management icon — track employee training, competence and QMS awarenes

Stay on top of your employees’ training needs and progress with training templates, dedicated training spaces and our training tracker.

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Supplier
management

MedQdoc supplier management icon — monitor and evaluate suppliers for ISO 13485 and MDR compliance.

Register, keep track and follow up on all critical and non-critical suppliers with complete visibility by using our automated supplier management Case process.

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Change management
 

MedQdoc change management icon — capture and manage changes using structured, traceable QMS workflows.

Capture and manage all changes using a structured, traceable and automated process.

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CAPA management
 

MedQdoc CAPA management icon — identify and resolve issues through closed-loop corrective and preventive action workflows.

Identify, manage and implement improvements efficiently with our predefined, systemized and close-looped CAPA workflow.

Nonconformity
management
 

MedQdoc nonconformity management icon — identify and resolve deviations with automated workflow and notifications.

Identify, review and address all types of nonconformities effectively with our automated workflow and notifications system so that deviations never get missed.

Customer complaint management

MedQdoc customer complaint management icon — manage and track customer complaints through an automated and traceable process.

Manage and accelerate complaint resolutions with a prompt, straightforward and user-friendly complaints management process where customers have the option to register complaints directly to the system.

Template
management
 

MedQdoc template management icon — manage and customize validated QMS templates for regulatory compliance.

Customize over 160 pre-validated templates and adapt them to fit your organization’s needs and processes.

Download or list of templates

Case management and automated workflows

MedQdoc case management icon — automate CAPA, NC, and other QMS processes through structured workflows.

Take full control over your organization’s processes by creating custom and business-specific workflows or using MedQdoc’s predefined best-practice workflows.

Digital workflows and streamlined interface

MedQdoc digital workflow icon — intuitive user interface for efficient quality management.

Ensure total quality control with MedQdoc’s user-friendly, intuitive and easy-to-navigate interface and digital workflows.

EU Commision webpage

“I have had the pleasure of performing multiple internal audits on two different companies both using the eQMS MedQdoc. This system is well designed, user-friendly and facilitates not just document control but also effective case management. MedQdoc gives a good overview of the Quality Management System and provides users with the relevant documentation and information as and when required. I wholeheartedly recommend this well-designed system.”
Melanie Janbro, Quality Consultant, Vinga Medtech Q Consulting

Quote

Business professionals reviewing MedQdoc eQMS features on a laptop during a quality and compliance meeting

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Medical Device Blogs

How to prepare Your QMS for IVDR and ISO 13485 — Without Drowning in Work

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Medical Device eQMS

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