Quality Management Software for Medical Devices

What are the Major Quality Challenges in Medical Devices?

Medical devices are vital components of the healthcare ecosystem. They aid the medical professionals to deliver healthcare services successfully. Today, when the burden of diseases and pandemics is set to go up, medical devices have greater role in providing infallible diagnoses and treatments.

But this prolific industry faces its own set of major challenges too. Apart from maintaining product quality and navigating through stringent industry regulations, the affordability of these devices proves to be a concerning aspect in influencing their demand in the market. This straight away hampers the revenue and profit margin of the company.

Also, this has led to increased proliferation of counterfeit and cheap devices which might put patients in danger. The only differentiating factor that can make your devices stand out is Quality, something that can’t be achieved through manual methods or spreadsheets, but only through a dedicated Quality Management System for Medical Devices.

A medical device quality management system is a digital tool that helps comply with structured set of procedures ensuring quality-driven operations throughout the organization to create safe and effective products.

Quality Management System For Medical Devices
Medical Device Quality Management System (QMS)

How does a Quality System for Medical Devices Industry help address these challenges?

Features of a Medical Device QMS

Efficiently identify, document, analyse, and segregate, non-conformances from internal/external sources, for further investigation…..Read More

Execute containment actions to systematically mitigate all the NCs and ensure steps to prevent their recurrence…..Read More

Right from identifying, recording, and associating complaints with NC & CAPA to their resolution, manage the complete lifecycle of customer complaints seamlessly….Read More

Streamline the training processes necessary for medical device personnel, including compliance requirements, and effortlessly track and manage all training records….Read More

Establish a proper workflow for documenting changes related to your design controls or device master records and automate and manage every step of the change control process…Read More

Store, create, track, retrieve, and manage all types of crucial documents such as design activities, design review policy, design history file (DHF) etc. through the value chain…..Read More

Assess future risks and their impact and drive continuous process improvement through risk control and mitigation

Perform audits based on your device classification. Right from planning, scheduling, to conducting and reviewing findings, streamline the entire audit process with ease…..Read More

Benefits of Medical Device Quality Management System

Benefits of Quality Management System

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