What features should you request for your ISO 13485 QMS?

A Conversation With Jon Speer & David DeRam, Greenlight Guru

ISO 13485 is just one of the International Organization for Standards’ (ISO) thousands of international standards. Earning an ISO 13485 certification for your medical device quality management system (QMS)—or working with a partner that has earned one—proves that your company meets the international gold standard of quality in terms of customer satisfaction, regulatory adherence, and more.

There are many elements that go into an ISO 13485-compliant QMS. We sat down with Jon Speer and David DeRam from Greenlight Guru, a leading eQMS vendor for medical device companies, to discuss the top features that medical device companies request for their ISO 13485 QMS. Here’s what we found.

1. Document Management

Document management continues to pose significant challenges to medical device companies of all sizes. New product development, testing, regulatory affairs, quality assurance, and commercialization require extensive documentation—and extensive documentation requires an effective system. Losing track of just one document, or completing a form incorrectly, can jeopardize any one of those steps on the path to commercialization.


“The long-term success of medical device companies depends on the strength of their foundation. Good document management is a critical component of this foundation—and in fact, it might be the most important part—because it’s the repository where all of the objective evidence and proof surrounding an organization’s products are housed.”
Jon Speer, Greenlight Guru, Founder and VP of QA/RA

But what makes a document management system effective and ISO 13485-compliant?

Many medical device companies have made a complete or partial switch to an electronic quality management system (eQMS). Traditional paper QMS systems may be comfortable, but they are also incredibly vulnerable to risk. In contrast, eQMS technology stores everything on the cloud and offers several other documentation benefits:

  • Accessibility & Consolidation: All documents (old and new) are accessible in the system, whenever and wherever you need them. Nothing gets lost in file cabinets or on stray Post-It notes.
  • Error Reduction: Avoid loss, duplication, mishandling, and other human error through eQMS automation.
  • Signature Capture and Time Stamping: Feel confident that all required approval signatures and accurate timestamps have been captured and preserved in the electronic system.
  • Version Control: All employees can access and work from the most up-to-date version of every document, wherever they are.


“Companies that have switched to an eQMS see the documentation benefits immediately. It’s easier, faster, and dare-I-say fun to electronically manage and approve documents. As with any form of change, the initial switch will take effort, but it’s worth the time and financial investment. Kapstone has assisted numerous customers set theirs up and we’d be happy to help you if you’re not comfortable.”
Justin Rowland, Kapstone Medical, Director of Business Development

Check out this resource from Greenlight Guru for more information about document management and how to do it right.

2. Closed Loop Traceability

Regulatory bodies across the world are placing a new emphasis on closed loop traceability, or CLT. CLT refers to a medical device manufacturer’s ability to “close the loop” between pre- and post-market activities—in other words, to share traceable information between teams that work across the development lifecycle. If something happens in production, the marketing team needs to know about it, and vice versa.

Jon Speer acknowledges that building and maintaining closed-loop traceability can be extremely difficult, particularly when done manually.


“To be fair, CLT is much easier said than done. Without a purpose-built quality system equipped with capabilities to achieve full life cycle traceability, cross-referencing items between multitudes of spreadsheets and documents could take weeks—if not months—with no guarantee of effectiveness.”
Jon Speer, Greenlight Guru, Founder and VP of QA/RA

Read more on closed-loop traceability from Greenlight Guru here.

CLT is a major pain point for medical device companies. However, investing in this core QMS requirement can help your organization work more transparently, efficiently, and cost-effectively. Whether you choose to optimize your manual systems or implement an automated, CLT-enabled electronic QMS (eQMS), Kapstone can help you close the loop.

3. Quality Event Management

Even the most diligent medical device companies have trouble responding to quality events efficiently. Greenlight Guru CEO David DeRam notes that “historically, when it comes to handling quality events, quality professionals rely heavily on the processes defined in work instructions, various forms, flow diagrams, and other disconnected documents to better understand their next step.”

Disconnected documentation facilities disconnected and inefficient quality event responses. Add in the industry-wide pressure to move quickly and medical device companies are left scrambling to restore quality standards without the tools or time to do so. This process is cumbersome, prone to error, and often very expensive.


“Historically, quality professionals rely heavily on the processes defined in work instructions, various forms, flow diagrams, and other disconnected documents to better understand their next step.”
David DeRam, Greenlight Guru, CEO

It is no wonder that many companies are asking for a better quality event system. Greenlight Guru delivers with their industry-leading eQMS, which leverages machine learning and other cutting-edge technology to automate quality event responses. No more scrambling to pull together a response; with this ISO 13485 QMS in place, your team can rest assured that you’re prepared to respond to any and all quality events. You can read more about this feature here.


“Kapstone has used an eQMS platform since 2017 for our own internal system, and we have helped implement an eQMS for various companies over the years. Whether starting from scratch or migrating a current paper-based system, it’s well worth the effort to set up an electronic system, and we’re comfortable to assist you if you need it.”
Katelyn Jessup, Kapstone Medical, Quality Manager

4. Integrated Training Management

Medical device companies recognize that one mis- or under-trained employee can jeopardize the success of a quality event response, or the efficacy of an entire interdependent quality management system. Having a system to set up and delegate training right at your fingertips can greatly streamline a company’s training process.

Quality assurance is a team effort. Every employee has a role to play to ensure that you’re delivering quality for your customers and that inefficiencies can be identified and fixed quickly. Greenlight Guru’s eQMS offers a streamlined solution to deliver the right training for the right people at the right time.


“Training continues to come up more and more during audits and, until now, it has been difficult for medical device companies to keep their entire training process organized and accessible. With Greenlight Guru’s Training Management, trainers can prepare training activities in a couple of clicks, then track and provide objective evidence that your employees have been effectively trained on processes, procedures, changes, and updates - all in a single, integrated closed-loop quality system.”
David DeRam, Greenlight Guru, CEO

Read more about the Greenlight Guru training system here.

5. Product Development

Quality assurance is no longer an after-the-fact assessment. It’s a core part of every stage of the development process, and one that isn’t possible without some degree of automation. As the world becomes more technological and interconnected, medical device companies are coming to understand that their product development processes should be, too.


“For the industry’s top performers, quality isn’t just a buzzword—it’s a cultural value. Quality-as-an-Asset means building quality into every stage of the organization, from device design and development to sales, manufacturing, and post-market surveillance.”
Jon Speer, Greenlight Guru, Founder and VP of QA/RA

Kapstone has always taken a fully integrated approach to new product development, weaving our expertise in design, engineering, manufacturing, regulatory affairs, IP strategy, and quality assurance into the full development lifecycle. We can partner with your team to build and maintain systems that will deliver the results you need on time and on budget. But more importantly, we’ll help you foster a culture of quality that extends from conception through to compliance and commercialization.

For a more in-depth look at the state of medical device product development and how companies can commit to fostering a culture of quality, check out this Greenlight Guru report.

Get Expert Quality Assurance Training and Consultation

Kapstone Medical partners with vendors like Greenlight Guru to offer efficient and effective quality management consultation to our clients. We can help you transition your QMS into the technological age, maintain it, and optimize it over time to deliver the results you need.

Contact Kapstone Medical to get started today.

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