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.
How does a Quality System for Medical Devices Industry help address these challenges?
- Regardless of the industry type, a QMS software is now a necessity in this post-pandemic, quality-conscious world. And when it comes to the healthcare industry, a purposeful QMS software for medical devices like BM QualityMaster is the key. It is a complete, web-based regulated system that can handle everything from supplier management, risk management, complaint handling, NC, CAPA, training management, product labelling, and more.
- Its personalized cockpit is the single-point access to manage, control, navigate and perform all crucial tasks to rope-in continuous improvements. A wide range of out-of-box reports, that too fully customizable, and interactive dashboards, establish end-to-end visibility at every level of production, ensuring product quality and no reworks.
- BM QualityMaster prioritizes patient safety in the medical devices industry, providing risk management and aiding in compliance with stringent regulatory standards like Current Good Manufacturing Practices (GMP), 21 CFR Part 11, Annex 11, and ISO: 13485.
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
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
- Promotes effective and faster execution of processes
- Increases customer satisfaction with precise manufacturing
- Elevates brand value by adhering to safety standards
- End-to-end traceability to reduce waste
- Increases efficiency by improving supply chain performance
- Enhances safety by reducing risks
- Growth in new customers, and increased retention by improving customer satisfaction
- Competitive advantage over the competition
- Improved decision-making process
