Finding & Selecting the Best Medical Device eQMS

Are you ready to electrify your QMS system?

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If you’re at a point where you’re finally ready to consider bringing in an electronic Quality Management System (eQMS) tool, or perhaps you’re looking to re-evaluate better options on the market, there’s naturally a litany of things to do and consider BEFORE you decide which tool to move forward with.

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This article covers most of the steps and considerations you’ll need to think through as you evaluate different electronic Quality Management System (eQMS) for your medical device company.? I’ve had the good fortune to help dozens of clients select eQMS tools and scale them to operational status.? Here’s what I’ve seen from a decision-making perspective, and of course some learned lessons along the way.

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WHAT IS AN eQMS:

The folks at Praxie did a superb job defining what an eQMS is, so we’ll borrow their definition: “An eQMS is a technology-driven solution designed to manage and monitor quality standards across an organization’s manufacturing processes. It replaces traditional paper-based systems, offering a centralized platform where all quality-related data and processes are stored and managed digitally. The primary role of an EQMS is to ensure consistent quality by automating and standardizing processes such as document control, audit management, and training management.

KNOW YOUR WHY:

As you look to bring in a QMS, including eQMS, one of the biggest considerations is to know your why – what’s driving the need.? What’s the reason you’re thinking of bringing in a tool in the first place?? Do you really need the tool or is it nice to have??

PRO-TIP – if you’re a pre-clinical startup there’s a good chance you might not need an eQMS just yet.? The old-fashioned traditional paper-based approach, while simple and cost effective, can be a realistic option.? That said, the manual paper-based QMS isn’t a long-term solution as it can bring about complications with time-consuming processes, human error and traceability.? ??

Most startups typically think about bringing in a QMS once they reach the design phase of the product development lifecycle as at that point implementing design controls becomes critical. (image credit: Medical Device Quality Management System (QMS) - SimplerQMS)

From there, the next thing your WHY will help you understand is how robust a system you need.? Read section ‘System Functionalities’ for further insights.

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REGULATORY REQUIREMENTS:

A good QMS ensures compliance with standards such as ISO 13485, FDA 21 CFR Part 820, and EU MDR, and helps maintain product quality and safety.? Is your company seeking to go outside the US (OUS) or remain domestic?? While you can certainly pick a QMS without knowing 100% what your regulatory strategy will be, it’s advisable to know that ahead of time as different tools offer different modules and layouts which may work more efficiently with a domestic strategy vs an OUS one.? The reality is you must still be compliant to FDA regulations if operating in the US due to site registration requirements.

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Secondarily, I’m of the opinion if I’m looking for a tool to support medical device QMS related needs I’m only going to look for tools which are largely, if not exclusively, designed for this purpose.? Trying to appropriate a tool which was initially designed for another industry, even pharma, into your medtech space is more of a band aide than a real solution.? Buy the right tool for the right purpose.

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ORGANIZATIONAL NEEDS:

Inevitably we may be splitting hairs here as some of this information will be similar in thought and approach to ‘Know Your Why’.? Picking the best QMS tool relies on you also knowing what you need out of it.? Things to consider are your company size (# employees and product lines), growth plans (scaling strategy and how a tool would need to grow in parallel with you), budget (what can you afford now, while taking into account setup costs, maintenance fees, licensing fees, etc.).? You’ll also want to think through the complexity of your technology as the more complex a product is the more advanced your QMS functionality needs to be in order to appropriately address areas like risk management and product/ process traceability.

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SYSTEM FUNCTIONALITIES:

QMS tools, like any other software tool, offer a variety of different features and user experiences.? No two tools are the same, or so they say.? When we’re considering a software tools functionality, we first need to be able to answer our WHY (why we need the tool) and what we’re hoping to do with it.? This will then help you determine if the functionality of a tool you are evaluating is appropriate.? For example, a popular QMS tool in the medical device industry is Greenlight Guru.? It does it all, and has a modern user interface experience, but it isn’t cheap and could be overkill for a pre-clinical startup.? Think about it like this – if you’re buying a car just to get you to the office 15 miles away, strictly for commuting, do you really need a car that has every bell and whistle on it?? Think about QMS tools this same way.? If you only need the basics you might want to stay away from the flash and glitz that comes with the bigger tools.? To further complicate things, and to play both side of the fence, robust tools like Greenlight Guru offer starter packages that allow you to add on modules as your company scales.? Is a starter package the right route? ?You’ll need to read on to decide.

Core functionalities to look for may include:

·?????? Document Control: Automated version control, electronic signatures, and easy document retrieval.

·?????? CAPA (Corrective and Preventive Action) Management: A robust CAPA system to identify, investigate, and prevent quality issues.

·?????? Risk Management: Integration with ISO 14971 (Risk Management for Medical Devices) for proactive risk identification and mitigation.

·?????? Audit Management: Tools to schedule, track, and document internal and external audits.

·?????? Training Management: Managing and tracking employee training, which is crucial for regulatory compliance.

·?????? Supplier Management: Evaluate supplier performance and ensure the quality of supplied components.

·?????? Complaint Management: Streamlined processes to track, evaluate, and resolve customer complaints.

·?????? Change Control: A well-structured process for managing changes to products, processes, or documents.

·?????? Validation Capabilities: Ensure the QMS software itself is compliant and validated for FDA or ISO regulations.

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