Fifteen Questions to Ask QMS Software Vendors in the Medical Device Industry

FDA Compliance

Fifteen Questions to Ask QMS Software Vendors in the Medical Device Industry

The answers will reveal the truth about your product and get it to market faster

Published: Wednesday, July 26, 2023 – 12:02

Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).

A QMS contains everything that internal teams, partners, and regulators alike must know to get a product to market and achieve its intended purpose of delivering better outcomes to clinicians and patients. The choices you make about the QMS you decide to implement will resonate throughout your product’s life cycle.

In an increasingly digital world, medical device professionals find themselves bearing the burden of paper-based systems when they could be automating their processes with a purpose-built software solution.

As a medical device professional, you have either realized the benefits of a software solution or been tasked with, advised, or ordered to find one. Lightly put, selecting the wrong solution could jeopardize the success of your company, leaving your team frustrated with rework, prolonged project timelines, and failure to maintain compliance.

Along the way of researching potential solutions, you find yourself in various conversations with vendors who spitball everything you need to know about their software. Before you can digest all the information, they ask, “Do you have any questions for us?”

As you stare blankly at the long list of notes that you have been taking and the items blurring together, you say, “Not at this moment—no.”

To avoid this scenario and prepare yourself to ask prospective vendors the right questions, we’ve come up with 15 questions medical device companies should ask quality management software vendors.

Asking these questions will uncover the information needed to make the best decision for your company and adopt a turnkey software solution that gets devices to market faster while acting as a single source of truth for your product development and quality activities.

1. Is the software purpose-built for medical devices?

As you begin your search for the right QMS software, you will familiarize yourself with the numerous software solutions that claim to get the job done but might not be built specifically for your needs.

General-purpose tools or QMS solutions sold into a broad number of industries fall into this category for medical device companies. Although they seem to be a potential fit initially, there are major burdens and hidden costs of implementing and validating these types of solutions.

In addition to increased costs and prolonged implementation and validation times, these systems lack the built-in controls for FDA 21 CFR Part 820 and ISO 13485:2016 as well as additional safeguards that purpose-built solutions provide. Choosing a solution that has industry-specific knowledge built into the system will provide your team with necessary guardrails while supporting the long-term health of your QMS.

While researching potential solutions for your company, it’s important to know:
• What industry the solution was first intended for
• What types of companies are using the solution
• What percentage of the software provider’s customer base is medical device companies

Narrowing your search to purpose-built solutions for medical device companies will save your team time and resources throughout their quest, and ultimately help them make the best, informed decision for a system that meets your needs as a medical device company.

2. Does the software align with major industry standards and market regulations?

The regulations put in place for medical device companies are understandably stringent to ensure that medical devices on the market are safe and effective.

Keep in mind that your QMS plays a large part in complying with these standards and regulations. Failure to comply or keep up with changes in the regulations can leave you stuck with time-consuming rework and added expenses for remediation efforts.

A key marker of operational excellence and efficiency for medical device companies is how well-prepared they are to face unannounced audits and regulatory changes—a major concern for many companies.

Noncompliance can be a large roadblock in your device’s life cycle, and a costly burden. One of the most commonly cited triggers for a 483 observation from the U.S. Food and Drug Administration (FDA) is failure to comply with CAPA, as well as issues like complaint records, process validation, design validation, and nonconformances.

It’s important to adopt a software solution that aligns with major medical device industry regulations and standards like:
• 21 CFR Part 820
• FDA’s Part 11 and the EU’s Annex 11
• ISO 13485:2016
• ISO 14971:2019

By implementing a QMS solution that aligns with these standards, your company will become audit-ready and maintain market competitiveness by staying ahead of regulatory changes.

3. Can the software meet the needs of a scaling and mature company?

Medical device companies often start with a very small idea: a device that works as a solution to an existing problem. But as the idea matures into a fully formed technology, it grows into a purpose to improve the quality of life for patients and providers.

In the same way, as your company grows, you may face obstacles that come with scaling a business—from an increase in audits to establishing more compliance measurements. So, when you’re choosing a QMS solution, it’s vital to vet the provider’s ability to grow with you.

By providing scalability, process efficiency, risk mitigation, and opportunities for continuous improvement, a robust QMS solution empowers organizations to navigate challenges, ensure compliance, and build a foundation for sustainable growth.

Investing in the right QMS solution is a strategic decision that not only addresses immediate quality management needs but also sets the stage for future success in an evolving business landscape.

4. Can the software manage design controls and risk management without add-ons?

Design controls and risk management are vital to one another throughout the production and life cycle of a medical device. Many companies fail to recognize the close connection between the two and create separate processes for managing both.

These companies fall behind by spending hours on managing documents, conducting design reviews, and retroactively mitigating risk.

By adopting a software solution that has built-in capabilities for integrating design controls and risk, your team can visualize in real time the relationships between individual design controls and associated risks.

For medical device companies offering SaMD solutions or physical devices with software components, confirm that the QMS solution you are evaluating includes a turnkey integration between design controls and the ALM of choice, such as JIRA, that comes validated and is Part 11-compliant.

When this is combined with purpose-built AI capabilities, your team gains visibility into your device’s design-control traceability and risk mitigation, as well as a streamlined approach to planning, conducting, and documenting design reviews as changes occur.

That’s why Greenlight Guru’s Risk Intelligence empowers medtech teams to be more effective, efficient, and confident in managing risk for their devices and their business.

Using a QMS software that integrates design controls and risk management ensures that your company will:

• Improve product quality and speed to market
• Align design controls with the business process
• Mitigate risk throughout the design phase and device life cycle
• Establish a foundation for demonstrating closed-loop traceability between design, risk, and postmarket surveillance activities
• Support a culture of true quality

Companies that have adopted this modern approach for their QMS save hundreds of hours yearly by using a purpose-built system that integrates design controls and risk with postmarket quality events for full traceability of their design and risk processes.

5. Can the software provide turnkey workflows for all major quality events?

Quality events such as CAPA, nonconformance, audit, and customer feedback are vital to maintaining and advancing the quality of your device, all while controlling risk and maintaining compliance.

Having turnkey, best-practice workflows for each of these quality events will streamline your teams’ efforts for:
• CAPA: Your QMS should allow you to streamline the CAPA process and easily trace events back to their root cause. This will help your team mitigate patient and business risk while maintaining traceability to any course or event that triggered the need for a CAPA.
• Change management/change orders: Identify, assess, and track changes while ensuring that documents and records are reviewed and approved through traceable change-management workflows. This will help your team track the effectiveness of change activities and ensure full traceability within a single source of truth.
• Nonconformance: A nonconformance workflow will enable teams with the tools to easily capture defect details, assess risk, and collaborate with the right team members or suppliers to quickly resolve the issue.
• Audit: With an out-of-the-box audit workflow, teams can jump right in to effectively controlling and conducting internal, external, or supplier audits.
• Customer feedback: Having a robust customer-feedback workflow supports your team in capturing both customer complaints and product feedback that are incorporated back into your device’s design.

6. Does the software tie postmarket surveillance activities to design controls and risk?

The medical device industry is moving toward closed-loop traceability (CLT) throughout the total product life cycle.

Closed-loop traceability is the ability to connect people, processes, and data seamlessly across the value chain. For example, product-related complaints or nonconformances can be traced back to specific design control elements, CAPAs, audits, or change orders they are associated with.

When adopting a software solution, you want to be sure it is capable of automating and streamlining processes to ensure a closed-loop quality system with full traceability between your design and development activities and postmarket surveillance activities while also allowing you to effectively manage quality events that occur throughout the product life cycle.

With a closed-loop quality system, you will gain visibility into your quality processes to understand how they affect one another. This enables a proactive approach to assessing and identifying issues before they become systemic.

If your device’s risk is affected by a postmarket quality event, traceability is key for identifying the root cause. A closed-loop system allows you to connect those processes for updating your risk-management file to ensure you are delivering a safe and effective product while ensuring that both design and development and quality processes are all risk-based and in alignment with ISO 14971:2019.

Being able to demonstrate CLT is one of the best tactics for companies to ensure quality and provide compliance. Those that can demonstrate CLT are far more likely to feel confident and perform well during audits.

Ask your vendor how their solution ties all major medical-device quality events back to design and risk activities to achieve closed-loop traceability.

7. Can the software help create a truly paperless audit?

Managing, sorting, routing, and printing piles of papers from your QMS is a method of the past. The purpose of going digital is to avoid these scenarios and streamline your audit activities—while avoiding the conundrum of paper.

Adopting a cloud-based software solution will transition your team from a paper-based system into a robust document management workspace that supports a high volume of documents. This will enable your team to work collectively in the system to organize and share relevant documentation and prepare for upcoming audits.

The QMS software solution you elect should also have built-in capabilities and workflows that allow your audit team to stay ready by keeping up-to-date procedures and records at your fingertips.

When it comes time for your audit, you can seamlessly work within your QMS to present the information to your auditor with ease.

Do not hesitate to ask your vendor for success stories about their customers achieving paperless FDA, ISO, or MDSAP audits using their software solution.

8. Can the vendor offer support from people experienced with the medical device industry?

Choosing a software provider means choosing a partner and establishing a trusted business relationship. When you view your relationship with your software provider as a partnership, and not so much as a transactional relationship, you will see endless benefits.

When analyzing software solutions, it’s important to know who is responsible for supporting the implementation, its continued use, and whom in the vendor’s company has experience in the medical device industry. Depending on your own experience and knowledge, these industry experts can work as an extension of your team.

It’s good to ask questions like:
• Have you designed or launched medical devices?
• Have you managed quality systems for medical device companies that actively sell devices?
• Have you experienced an FDA or notified body audit firsthand? Do you have experience in conducting audits?
• Do you thoroughly understand ISO, FDA, and EU MDR regulations?

This will help you get a better feel for the scope of advice and additional services that the software provider can offer.

Companies will benefit from a provider that has a team experienced in working in the medical device industry, one that can help guide system implementation, stay up to date on best practices, and navigate pending regulatory changes.

9. How quickly can the QMS software be implemented?

A software implementation can consume a lot of time and energy. That’s why it’s important to consider the total costs of implementing a software solution.

For companies that choose customizable solutions, it can take months or years to get those workflows correct and validated. For other solutions, the system’s lack of intuitiveness may prolong onboarding timelines and require additional training.

Ask software providers about the effort required to start using the software and the average time-to-value for new customers. Because software validation, training, and other implementation details can be both time-consuming and costly, it’s fair to ask the vendor how quickly your team can be up and running with the system.

Another thing to consider is the team behind the software:
• Who will be training you to use the system?
• How knowledgeable are they about the regulations and using a QMS?
• Will they understand how the ISO 14971 standard for risk applies to your devices?

Additional resources they may be able to provide are QMS SOPs and templates that are proven across FDA, ISO, and MDSAP audit requirements. Although these may not be a necessity for your company, they can benefit those looking to get their system up and running quickly with any necessary guidance, rather than starting from scratch.

Having experienced medical device professionals as your onboarding and support team can help you better understand how to use and leverage the system to your team’s advantage.

Greenlight Guru’s out-of-the-box solution comes with validation protocols and audit-proven SOPs, templates. Customers can be up and running with an audit-ready QMS in 30–45 days.

10. Will the software help users stay ahead of regulatory changes?

Knowing industry best practices is one thing; adopting them and actively staying ahead of the industry is another.

Many regulatory changes coming in the near future are making these best practices a requirement for medical device companies. EU MDR is merely the first instance of needing to demonstrate closed-loop traceability throughout the product life cycle.

Ask your software vendor if its system and workflows not only align with current compliance requirements but also stay ahead of them by implementing industry best practices as regulation changes occur. This will enable your company to stay ahead of these changes and maintain or advance your market competitiveness.

It’s also a benefit to know the face behind the screen. Knowing the industry experience and knowledge of those who develop the software is an added plus for your company’s peace of mind that the software is compliant with industry standards and following industry best practices.

When deciding whether a vendor is a good fit for your company, ask if it’s dedicated to keeping the software up to date and in compliance with changing regulations.

11. Is there access to reliable, high-quality data from the software?

In an increasingly digital world, data have become a cornerstone of operational success for medical device companies. Gaining visibility into your quality system via accessible data enables teams to measure efficiencies, business decision-making, and more. It’s vital that the chosen solution can give you reliable data insights into the health and strategic positioning of your company, your device’s quality, and the processes in place.

The ability to make data-driven decisions will advance your team’s ability to make informed decisions and work efficiently and effectively while also giving you a leg up on your competitors.

What medtech companies need is a cloud-based QMS software that is a connected source of truth and allows you to manage multiple processes in a single system, all while being equipped to access and share those data with other tools you use.

12. Is ongoing software validation included with the software at no additional cost?

When adopting a software solution, it’s important to consider the ongoing effort and costs associated with maintaining your QMS over time. One of the most notable ongoing costs is the time, money, and effort required to validate the software to 21 CFR Part 11 requirements. 

Many software solutions that allow customization or configuration of their systems’ workflows require revalidation and additional configuration when the software is updated or modified. It’s important to ask if any incremental costs are associated with software validation. These costs and the time spent on revalidating can add up if the software provider is regularly updating and releasing new functionalities.

It’s important to know what the standard protocol is for new software releases and whether the vendor includes a software validation package with the new release.

The ideal scenario would be to adopt a QMS software solution that includes a validation protocol package at no extra cost to your company for each new software release.

13. Is the software built with a secure, modern architecture?

Knowing the type of software architecture will help you better understand how your software is deployed, updated, maintained, and kept secure.

A secure, modern software application is typically built with a multi-tenant, cloud-based architecture.

Using software solutions built on a multi-tenant, cloud-native architecture is vital to ensuring that you’re adopting a system that follows modern best practices for application architecture, data storage, backup, and encryption, and provides high availability that can serve end users globally. 

These solutions also positively influence the effort and costs associated with validating the system to 21 CFR Part 11 requirements, which in turn affects the total cost of ownership (TCO) associated with the solution.

According to LNS Research, the real differentiator is multi-tenant cloud offerings. Cloud-based technologies create new opportunities to streamline validation. Through the cloud, industry-leading vendors are providing prevalidated platforms, functions, and preconfigurations. There are several vendors that have invested in developing near-zero effort or even true, no-effort validation environments. One approach comes from a multi-tenant SaaS (software as a service) platform that prevalidates its platform and completely avoids customizations and configurations through options management. Every customer is automatically validated to every update.

In addition to the benefits associated with system scalability, data security, and validation, solution providers with multi-tenant cloud applications are more likely to demonstrate a cloud-native mindset that allows them to deliver new software capabilities at a rapid pace and innovate faster than QMS solution providers with single-tenant solution offerings.

14. What kind of training and educational resources does the QMS vendor offer?

The best QMS solutions are more than just a tool; they are a hub for continuous improvement within your organization. One of the best ways to do this is with training material, such as online learning and certifications. Another way is by allowing easy access to customer support channels to which your team can turn for answers when needed.

With more than 300 thoughtfully curated courses designed by top industry leaders, Greenlight Guru Academy provides an opportunity for all learners to advance their skill sets with accessible industry knowledge and self-paced models. These courses are taught by medtech experts, and many of the instructors have helped write today’s medtech regulations.

15. What is the software’s return on investment?

Implementing a QMS is key to the success of a medical device company and the speed at which it can operate. However, success can be more difficult to achieve with a paper-based QMS or generic tools, which one in three medtech professionals say they use for essential activities like documentation, product development, compliance, and training.

This approach creates inefficiencies and increases the risk of noncompliance. As a result, about a third of medical-device industry professionals say they’re not well equipped to meet quality and product development standards.

In an independent study by Hobson & Co., research showed that companies can experience significant increases in speed and efficiency, along with a reduction in risk, by implementing modern medical-device QMS solutions.

To find out the potential return on investment when choosing an eQMS solution, check out Greenlight Guru’s Value Calculator to get a free, customizable report.

Published July 3, 2023, on the Greenlight Guru blog.