Jon Speer
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Articles by Jon Speer
Quality Assurance (QA) vs. Quality Control (QC) in the Medical Device Industry
Imagine that your medical device malfunctioned during patient use. Do you know whether quality assurance or quality control is responsible? When working through remediation efforts, do you know which quality function demands the attention, or should you make improvements to both? More often than we may like to admit, a vast majority of medical device professionals do not have a full grasp on the acronyms and meanings of core industry terminology relevant to their role.
ISO 13485: The Ultimate Guide to Medical Device QMS Requirements
ISO 13485 is the international standard for quality management systems in the medical device industry. It sets the requirements an organization must meet to design, produce, install, and service medical devices, and it is the standard notified bodies and regulators audit against. The current edition is ISO 13485:2016, published in March 2016 and confirmed as current by ISO in October 2025.
PMCF data collection: when surveys work, when they don't, and what regulators actually expect
Post-market clinical follow-up (PMCF) surveys are widely used. They are not widely understood. Manufacturers reach for them because they look manageable, they can be run without ethics committee involvement in many cases, and they produce data fast. What they often fail to account for is that the EU Medical Device Regulation (EU MDR) has a very specific view of what counts as credible clinical evidence, and a badly designed survey does not get manufacturers any closer to it.
5 Elements that Must Connect to Your Design Controls for an Audit-Proof QMS
Design controls are a set of quality practices and procedures that are used to ensure a finished device meets its user needs, intended use(s), and specified requirements. The requirement for medical device companies to use design controls is enshrined in 21 CFR Part 820, as well as ISO 13485:2016.
How to Set Up Clinical Studies to Comply with US FDA Regulations
For manufacturers of high-risk medical devices, obtaining data from clinical investigations will be essential to a successful regulatory submission in the US. The Food and Drug Administration (FDA) requires all Class III medical devices to go through Premarket Approval (PMA) prior to being placed on the market in the US.
Quality Assurance vs. Quality Control in the Medical Device Industry
Operations Quality Assurance vs. Quality Control in the Medical Device Industry The highest quality is a combination of the two Published: Tuesday, June 7, 2022 - 12:03 Imagine that your medical device malfunctioned during patient use. Do you know whether quality assurance or quality control is responsible? When working through remediation efforts, do you know which quality function demands the attention, or should you make improvements to both?
Seven Project Management Tips
Management Seven Project Management Tips How project management complements product development Published: Tuesday, November 23, 2021 - 12:02 When I began my medical device career, I started as a product development engineer. Part of the role included—right, wrong, or indifferent—project management. And I’ve found throughout my career and from discussions with hundreds of others in the industry that this is commonplace.
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Closed-Loop Traceability for FDA Compliance
FDA Compliance Closed-Loop Traceability for FDA Compliance How to do it in real time Published: Wednesday, June 2, 2021 - 12:01 Demonstrating identification and traceability in all quality system processes is a must for medical device companies to comply with FDA regulations. To satisfy this compliance need, companies will need to connect related processes within their quality system to close the loop between related pre- and post-market activities and processes.
How to Structure Your Medical Device Technical File
Health Care How to Structure Your Medical Device Technical File Modern methods of documentation compliance Published: Tuesday, May 11, 2021 - 12:02 The medical device technical file is a must-have document for devices to be sold in the European Union (EU) marketplace. The file contains detailed information about your medical device, its design, intended use claims, composition, and clinical evaluations. It’s essentially an “everything you must know” document for a device.
What Are the Biggest Changes under EU MDR?
The compliance deadline for the new EU MDR is right around the corner. With new regulations come new processes affecting medical device companies. Time is of the essence with nearly one month remaining, and manufacturers still have much to consider before the deadline. But which of the changes under EU MDR are impacting companies the most? And what is the best way to respond?
MedTech Intelligence Volume 13 Issue 17
EU IVDR - Process, Data, Reporting & Planning The European In Vitro Diagnostic Regulation (EU IVDR) will profoundly affect the global diagnostics market, requiring new procedures, evidence development, documentation, organizational structures, data management, reporting, and a reassessment of legacy portfolios. Preparation will involve strategic thinking and buy-in at the highest levels. Implementation of IVDR is scheduled for May 2022, with no indication that it will be deferred.
Why You Must Have a Single Source of Truth for CAPA
Corrective and Preventive Action (CAPA) is a major process that lives within the quality system of medical device companies. It is used by quality professionals to investigate and solve issues, identify reasons for fault, and initiate actions to understand the cause and prevent recurrence of issues found. Yet, year after year CAPA remains one of the top reasons for FDA to issue 483 observations, typically due to inadequate processes or inconsistent adherence to regulatory requirements.
Unannounced Audits
FDA Compliance Unannounced Audits A survival guide for medical-device quality managers Published: Wednesday, November 18, 2020 - 12:02 The medical device industry is one that requires preparation. Unlike less regulated industries, there’s an expectation in the industry around the possibility that an inspector or auditor can show up without notice and stop a business in its tracks.
Traceability Requirements in EU MDR
Image by Rob Grant from Pixabay Medical device manufacturers marketing products in the EU must ensure traceability between all stages of medical device development and post-market activities. Jon Speer | Nov 12, 2020 In May 2021, Europe’s medical device regulation (EU MDR) will go into effect, replacing the existing medical device directive (MDD) that is currently in place.
Culture club: Three keys to building a foundation of quality
Jon Speer, founder and VP of QA/RA at Greenlight Guru offers his thoughts on developing strong quality control and assurance culture in the medical device industry. Change has always developed at a rapid pace in the medical device industry. These changes compounded with new challenges brought forth by COVID-19 can leave industry leaders feeling uncertain about how to innovate and ramp up production to meet soaring demand, all the while ensuring quality remains a core focus.
The Importance of Managing and Controlling Risk in the Medical Device Industry
Health Care The Importance of Managing and Controlling Risk in the Medical Device Industry Knowing where to prioritize is key to successful mitigation Published: Tuesday, September 8, 2020 - 12:02 Imagine you’re a patient going in for any medical procedure. You probably think very little about the risks of the medical device being used on you.
Ensure Success Throughout the Entire Medical Device Lifecycle
Image by Pete Linforth from Pixabay Medical device experts advise focusing on quality at every stage. Jon Speer | Aug 04, 2020 There are more than in the United States alone. Each of these organizations is constantly developing new devices, not to mention upgrading those already on the market, which is why many industry professionals are frequently seeking ways to ensure success throughout the entire medical device lifecycle.
Best Practices for Leading Medical Device Teams During the COVID-19 Pandemic
The current state of the world has created challenges for nearly every industry, and the medical device landscape is no exception. As COVID-19 sweeps the globe, it’s becoming increasingly difficult for medical device leaders to navigate the arising challenges and prepare for the future. In my current position, I have experienced this firsthand. The medtech industry is racing toward innovation to create the necessary technology to fight the virus both now and for years to come.
MedTech Intelligence Volume 12 Issue 23
Volume 12 Issue No. 23 Business Analysis Combination Products Market Access Operations Product Development Quality/Regulatory Soapbox Electronic Product Information: A Roadmap to the Business Benefits By Agnes Cwienczek, AMPLEXOR Digital technologies offer more efficient and patient-friendly distribution of the up-to-date manufacturing details and safety advice mandated by regulators.
COVID-19’s Impact on the MedTech Industry: How to Get Through
Within the medical device space, the COVID-19 pandemic has increased pressure to produce devices like ventilators and diagnostic tests at a record pace. Regardless of what the future holds, failure to act will only worsen the situation. While our adrenaline tells us to produce devices and materials rapidly, we must remain focused on quality. To successfully navigate the uncertainty and support public health initiatives, strategies used during this time must account for various factors.
What You Need to Know for an Effective Risk Assessment
Health Care What You Need to Know for an Effective Risk Assessment Two concepts to ensure patient safety and device quality Published: Thursday, May 14, 2020 - 12:02 Historically, risk management has been a complex and polarizing subject, with various stakeholders assigning different values on the probability and severity of harm.
Engineers: How to Curb Quality Myths Now
Medical device companies must operate on a best-of-breed level, meaning the idea of “true quality” is at the core of every aspect of the business. True quality is a foundation to build upon, not just a departmental responsibility or afterthought. Unfortunately, many medical device organizations still struggle to adopt this mentality and share responsibility across their business.
Three Myths Engineers Believe About Quality
FDA Compliance Three Myths Engineers Believe About Quality There’s always a way for medical device engineers to create and focus on true quality Published: Wednesday, April 1, 2020 - 12:02 Successfully run medical device companies are cross-functional. From product development, manufacturing, quality, and regulatory compliance, to marketing and sales, every business operation works together to produce and sell medical devices that improve the lives of end users.
FDA Form 483 Observations and Warning Letters: What’s the Difference?
FDA Compliance FDA Form 483 Observations and Warning Letters: What’s the Difference? What you should know and what you should do Published: Wednesday, March 11, 2020 - 12:03 If you’re a medical device company manufacturing Class II or Class III devices, you can expect to have the U.S. Food and Drug Administration (FDA) turning up for an inspection. It’s what happens after that inspection that we’re concerned with in this article.
Paper Processes: Three Reasons It’s a Costly Business Move
When businesses plan to cut costs, they’ll often take measures like cutting department budgets or downsizing office space. But one of the costliest factors that most businesses are unaware of, especially medical device companies, is their reliance on paper-based processes. A single ream of paper might only cost around $10, but when you’re relying on it as a medical device quality management system (QMS), that cost can quickly get out of hand.
Paper Is Expensive
Management Paper Is Expensive Three ways a paper-based quality management system can cost your company big time Published: Monday, February 17, 2020 - 12:02 Believe it or not, paper is very expensive. Although the going rate for a ream of standard copy paper is only about 10 bucks, the expense of relying on paper for your medical device quality management system is downright outrageous.
4 Keys to Funding Your Medical Device
When it comes to leading a startup, one of the most relevant and frequent conversations is about securing funding. Common questions such as how long will it take to raise and how much is needed are typically the first to come up. However, the most crucial question organizations should ask themselves is how they can make themselves more attractive to investors.
MedTech Intelligence Volume 11 Issue 50
Volume 11 Issue No. 50 Business Analysis Combination Products Market Access Operations Product Development Quality/Regulatory Sponsored Content Take a Closer Look at the Components in Microfluidic Devices Manufacturing microfluidic devices requires sophisticated techniques. Reimagining Eye Care in Asia By Mary Kan and William Greene, Singapore Biodesign The future of eye care will sit at the intersection of the digital and physical worlds.
We’re going through changes: Major upcoming regulatory changes for manufacturers explained
Jon Speer, founder and VP of QA/RA for software company Greenlight Guru, explains the major regulatory changes which are coming soon for manufacturers of medical devices. Between the transition to ISO 13485:2016, the EU MDR and political instability, the past five years of regulatory changes in the medical device industry arguably represent more change than the industry has seen in 20 years.
Top 3 Mistakes You Can Make When Adopting ISO 13485
There are estimated to be 5,300 to 5,600 medical device companies in the United States alone, each with new, cutting-edge technologies. However, as advanced as these devices must be, above all else, they must operate safely. The International Organization of Standardization (ISO) developed the standard ISO 13485, which provides guidelines around the quality management of medical devices. Although ISO 13485 is helpful as a harmonized standard, there’s one catch.
FDA Cleared vs Approved vs Granted for Medical Devices
As a medical device professional, you are well aware of how much time and effort goes into getting your product to market. So, with so much care put in every part of the device, shouldn’t you be taking the same sharp eye to detail when it comes to the language you use in marketing it? You have likely heard the terms Clearance, Approval, and Granted used many times throughout the medical device industry. You’ve likely heard them used interchangeably. You’ve likely even heard them used incorrectly.
Five Tips From Medtech Executives on the Value of Quality
FDA Compliance Five Tips From Medtech Executives on the Value of Quality We all benefit from a larger perspective Published: Tuesday, October 22, 2019 - 12:02 When it comes to making medical devices, quality is key. That’s a concept that nearly every medical device professional agrees with, but what does it mean? Why is quality so important, and how should it be pursued? These are the questions that medtech executives and company stakeholders should be asking themselves and their teams.
Qualifying Your Suppliers Using a Risk-Based Approach
FDA Compliance Qualifying Your Suppliers Using a Risk-Based Approach Lessons from the medical device industry Published: Thursday, June 13, 2019 - 12:02 This notion of risk-based processes within quality systems is something that has become part of our formal lexicon following the release of ISO 13485:2016, the globally harmonized standard for medical device quality management systems (QMS).
How to Write Effective SOPs for Medical Devices
Writing and enforcing standard operating procedures (SOPs) for medical devices is required by FDA, ISO and other regulatory bodies. How effective are your SOPs? However, many medical device companies find this process to be rather confusing, resulting in ineffective procedures being written and followed. This confusion will likely be the root cause for subsequent inspectional observations that result in more serious consequences for the manufacturer, such as 483s and warning letters.
The Most Common Problems With Your CAPA Process
The corrective and preventive action (CAPA) process continues to be the most widely shared challenge for most medical device companies. While the regulations are relatively clear regarding well-documented CAPA procedures, their implementation is still one of the most common compliance issues companies get caught up on during product development. The greater good of your company, your product, and your end users hinges on the planning and execution of an effective CAPA strategy.
What to Expect During an FDA QSIT Inspection
FDA Compliance What to Expect During an FDA QSIT Inspection As a medical device manufacturer, you can expect to be inspected Published: Tuesday, March 19, 2019 - 12:03 You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US. Food and Drug Administration (FDA) is fully within its rights to show up unannounced at any time.
Best Practices for Effective Medical Device Design Reviews
Design Reviews are intended to be checkpoints during medical device product development to ensure the product design is safe, effective, and progressing.Design Reviews are moments in time during design and development to ensure the device being developed is on track and in alignment with expectations. Design Reviews are also a way to ensure Design Controls are being captured and documented throughout the project.
How to avoid a medtech document scavenger hunt
I love a scavenger hunt as much as the next person. However, when it comes to medical device documents and records, your system and approach should not be the makings of a scavenger hunt. Whether you have been through this before or if this is the first time, take a few moments to consider the importance of the documentation of your medical device company. Sure, you have to consider the regulations—FDA, ISO, and so on.
Five Common Mistakes Companies Make With CAPA
We raise the corrective and preventive action (CAPA) topic often because it is still something that companies tend to struggle with and find themselves in hot water over, particularly when it comes to regulatory audits or inspections. There’s often a sense that CAPA is another inconvenient process that takes resources away from those preferred revenue-generating tasks, but in reality, failing to give CAPA appropriate focus can cost a company greatly.
For electronic medical device developers, here's what you need to know about IEC 60601 standard
IEC 60601 is different from other regulatory compliance processes and can be challenging for medical device developers in this category. You’ll find that you need to take different requirements into account, depending on the intended end-use of your device. I recently had a chat with Leo Eisner, founder and principal consultant of Eisner Safety Consultants and a guy who knows 60601 inside and out.
A Guide to Medical Device Corrective Action and Preventative Action (CAPA)
As an experienced medical device professional who has worked with dozens of companies, from startups to mega multi-nationals, I’ve had the opportunity to observe, evaluate, and impact how these companies implement effective quality management systems. Time and time again, however, the one process that nearly always presents the most challenges to medical device companies, regardless of shape and size, is CAPA. That’s right, Corrective Action & Preventive Action.
Understanding FDA’s Guidance on Medical Device Reporting
A few months ago, the FDA released a guidance on medical device reporting (MDR), an important document with which manufacturers should familiarize themselves. It outlines expectations of reporting, and it is a vital part of post market surveillance. I recently had a chat with Mike Drues, president of Vascular Sciences, about MDR and what it means to medical device companies. What isn’t MDR, and why is it important? The following are a few of our thoughts on the state of MDR.
Why the FDA Presubmission Is an Underutilized Tool
That sentiment was really the basis behind the U.S. Food and Drug Administration’s (FDA) presubmission tool, as I was discussing recently with medical-device quality assurance and regulatory affiars expert David Amor during a webinar we did on the topic. There is always uncertainty baked into any kind of government submission process, and it’s helpful to companies if there is a way to tackle issues before submitting a 510(K).
A timeline to adopt medical device QMS (and why you need to act now)
To be blunt, if your company has put off doing anything about ISO 13485:2016, you need to act immediately. We’re in the window where there is less than a year until you need to be ISO 13485:2016 certified. There is no extension. ISO won’t accept any excuses – this has been published for at least two years now.
How To Structure Your Internal Audit Program
How To Structure Your Internal Audit Program How have the first few months of 2018 treated your company? Are you confident that you’ve got a good plan for the year, including internal auditing, or are you still scrambling to catch up from issues identified late last year? This is a scenario that plays out too often for companies, particularly when dealing with internal auditing. Make this year one of preparedness, and avoid the mad scramble by planning ahead for your internal audit program.
Here's what you need to know about FDA's new guidance on software as a medical device
Medical devices are a big business covering a wide range of modalities and applications. To ensure the safety of these devices, the Food and Drug Administration (FDA) publishes guidelines and regulations that assess the safety and efficacy of new devices that go to market. The FDA posted a guidance document in December last year which details its current thinking on one of the fastest growing trends in medical devices: Software as a Medical Device, or SaMD.
The Impact of Risk Management on CAPA
If you’re in the business of developing medical devices, then risk and risk management become synonymous with daily operations. Your overall task is to bring a medical device to market that not only provides a needed function to a patient but is also proven to be safe and effective to use. A product that may be used by someone who is near and dear to you, too. Risk management is a process that is very much here to stay in the medical device industry.
The Countdown to Implementing ISO 13485:2016
Have you started implementing ISO 13485:2016 yet? If not, I’m afraid I have to tell you that you’re lagging behind at this point. You have one year to go before compliance is an absolute requirement. Did you just break out in a cold sweat? Not to worry. You do have time to act, but you need to do so now. Here’s what you need to know with one year left to go… The Time to Act on ISO 13485:2016 Is Now ISO 13485 was revised back in March 2016 and has a three-year adoption period.
5 things to address if you’re a medical device startup
If you're at the ground floor of a new medical device startup, it's easy to get caught up in the rush as your company hurtles toward the next product milestone, the next round of investment, and the next steps in getting to market. However, if you're overlooking the critical details of regulations that permit you to sell your device, you could find yourself swamped in paperwork before you can get to market, or worse, not make it to market at all.
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