The importance of Quality Management Systems in the medical device industry

Consider a live musical show. All the instruments are well tuned, players are well synched, and orchestra is perfect to create a mesmerising effect.

Suddenly, one of the instruments gets detune. Now instead of adding value to the show, the instrument is making arbitrary sound.

Can you continue to enjoy the show?

The same thing happens with medical devices. Unless all the parts, circuits work in cohesion, the device cannot provide correct result.

An instrument getting detuned in a musical show does not affect life and death of a person, but a medical device showing wrong result can cost a life! Hence, the efficiency and correctness of a medical device cannot be compromised at any cost.

There is only one solution which can ensure perfect result from a device — QMS software for medical devices.

In this blog we will go through a journey to understand QMS, medical device industry, benefits of implementing QMS in medical device manufacturing and beyond.

Here we go……

• What is a QMS for Medical Devices?
• Importance of QMS in Medical Device Industry
• Benefits of Medical Device QMS Software
• Conclusion

What is QMS for Medical Devices

A medical device quality management software is a digital tool that helps organizations to abide by the predefined set of procedures. These set of procedures ensure that the organization follow quality backed operations for creation of safe and effective medical devices.

Importance of QMS in Medical Device Industry

The medical device industry is facing a lot of challenges. One side they must follow the industry regulations, at the same time they have pressure of bringing quality product at affordable price. Besides, having counterfeits in the market is also a soaring challenge for the healthcare device manufacturers.

A QMS helps to balance all the areas of a medical device manufacturing. It ensures that a quality product reaches the market in time and at an affordable price. Not only this, but the device coming in the market follows all the necessary laws and is compliant to regulatory norms.

Thus, it helps to keep up health of the patient and that of the manufacturing organization.

Benefits of Medical Device QMS Software

In the journey of quality medical devices production, the medical QMS helps in many ways. It helps to find the deviations, conduct audits, store documents and much more. By doing so, it ensures that the products and procedures stay compliant to the laws applicable to the industry.

There are various benefits of a medical device QMS software. Some of which are:

Efficiently manages documents — There are many documents that float within organization, among stakeholders, sponsors, investors, regulatory agencies throughout the life cycle of the product.

Arrange all the important documents like SOPs, procedures, policies, contracts, compliance certificates etc related to the organization at one place. Manage them with tagging and find them at just a single click.

This helps organizations to avoid last minute struggle during audits and refer to the documents quickly and easily.

A QMS for medical device automatically collects data, route documents for review and approval, and stores data at a single location.

Besides, the document management system of QMS for medical devices like BM QualityMaster facilitates version control which ensures that only relevant and latest document is in circulation.

Helps stay compliant — Medical devices must follow various compliances set forth by the regulatory bodies. Having defined set of procedures and rolling them in the organization are requirements of many regulatory norms. By having QMS software, organizations can ensure the same.

With controlled access to documents, having capabilities to take corrective and preventive actions, perform root cause analysis, and more, organizations follow various compliance mandates.

With a robust medical device QMS, like BM QualityMaster, organizations can tick various compliance requirement boxes.

Instils continuous quality upgradation — The ability of the software to document and refer CAPA helps organizations to improve processes, and procedures. If organization encounters similar issue or problem, this reference will help the organization to avert the issue, change the process or procedure and improve continually.

This way, it rules out the possibility of recurrence of any such issue or challenge in future.

Gives operational consistency — Since the QMS has set procedures, and functions, it sets a consistency in operation. This consistency of operation produces consistent products each time. Hence, the brand will produce quality products and consistent devices each time to gain edge over competition.

BM QualityMaster provides you a master SOP feature to arrange and view SOPs at a single click. Besides, the cockpit view provides personalized shortcuts of frequently used modules, ensuring necessary checks at every operation.

Finds skill gaps and streamline staff training — The staff of the organization must always be updated. Their skill sets must be upgraded as per their job roles and requirements. When any procedure or process is changed, due to change in technology, or otherwise, the skill gap so formed can be identified with the help of a QMS.

A QMS can help in fixing this skill gap by organizing training of the staff. QMS also streamlines the training and stores updated training records of the staff.

Training management module of BM QualityMaster helps to map the right trainer, identify trainees, maintain records of the training and schedule training of various staff members.

The software also enables easy course updates for compliance, process changes or equipment needs.

You can find plethora of benefits by going to Training management module.

Enhances internal communication and collaboration — A QMS shares data from a central repository, hence shares identical data to all stakeholders. It facilitates various members to collaborate and work simultaneously on the same file without interrupting other’s work.

Moreover, pre-defined workflows, conditional access control, visibility into the progress of tasks and activities, real-time notifications, and escalations foster internal communication and collaboration.

Simplifies Audits — Medical devices are sensitive. Their efficiency and precision help medical practitioners to take important decisions. Hence, medical devices must undergo regular audits to ensure that all the regulatory processes, procedures and practices are followed by the organization.

With medical QMS in place, these audits are easy to conduct.

Audit management module of BM QualityMaster facilitate to carry out entire audit process. From defining to documenting audit objectives, to scheduling to assigning tasks each process is fast and automated.

You can detect NC during audit, escalate them to CAPA and then seamlessly connect with change and risk management to take the next proactive steps.

Increases efficiency — QMS avoids ambiguity of role and responsibilities. It has clear mapping of role and responsibilities. Hence, as everyone knows his role, he performs with clear mindset. The clarity of role and responsibility brings consistency in work and avoids bottlenecks. This eventually increases efficiency of working people.

During any unlikely event, which can negatively impact the brand and its production, QMS documents corrective measures. This further goes to root cause analysis. By finding root cause, the organizational processes and procedures become more adaptive towards future events. Thus, making organizations more efficient today and everyday.

BM QualityMaster has role-based access facility to ensure access of data to authorized personnel only. Thus, defined roles have defined access, reducing confusion and chances of data mis-handling further.

Reduces cost — Since the devices are formed with standard instructions, procedures and processes, the quality is consistent. As the organization follows compliance norms, the product infused in the market has comparatively lower chances to be recalled.

This saves huge cost of product recalls, legal penalties, or brand dilution.

Also, with consistent and reliable products more customers get satisfaction which eventually boils down to increased profits.

Conclusion

Medical device industry is highly sensitive as its impact touches all strata of society. The malfunctioning of a device can have far reaching consequences. Therefore, the device must produce and continue to produce apt results every time.

This is possible only when the product is manufactured with set procedures. QMS for healthcare devices ensures that products that are being manufactured follow the laid procedures.

BM QualityMaster is the most preferred medical device QMS software in the industry.

Not only the software helps you to document process and procedures, but it also helps to follow various compliance like FDA, 21 CFR Part 11, ISO:13485, GMP etc.

Rely upon BM QualityMaster for all your medical device manufacturing quality concerns, visit BM QualityMaster right now to explore more benefits it offers to the industry and contact here to discuss further.