Global Medical Device Podcast powered by Greenlight Guru

When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the accompanying draft guidance left much ambiguity and confusion among manufacturers who struggled to understand what it was, why it mattered, and what to even do with it.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the recently published final guidance document on the UDI system from FDA.Listen as Jon and Mike provide clarity for manufacturers regarding the true intent of FDA's final guidance on the UDI system, explaining the nuances, benefits, and potential impact of UDI for medical devices and technologies in the US.Some of the highlights of this episode include:What is a UDI? Companies have different formats, technologies, or options available, such as an automatic identification and data capture system, to add barcodes, quick response codes, or RFID chips to devices and other products.Many companies are getting in trouble with the FDA because of some aspect of UDIs - whether it’s rejected regulatory submissions or manufacturing inspections generating 483 observations.Mike believes the reason why is because many people are focusing on following the UDI regulation (and guidance) without understanding its intent.Fundamental problems that companies are experiencing are not due to the details of UDI implementation, but not knowing or understanding the need to add UDIs to medical devices.UDI identifies the specific product, manufacturer, and batch, lot, or serial number. UDI is for traceability in case there is a problem, complaint, or recall.Challenges of implementing UDIs on labels include if the device is too small, software doesn’t include packaging, and patient compliance.Unique vs. Universal: Does ‘unique’ as defined in UDI by the FDA universally match the European Union and other regulatory bodies? It’s unlikely that a global or universal device identifier will be standardized.Memorable quotes from this episode:“It’s amazing to me how many companies, including some of my customers, are getting in trouble with FDA - whether it comes to regulatory submissions that are being rejected or manufacturing inspections that they’re getting 483 observations on because of some aspect of UDIs.” Mike Drues“It’s taking us, quite frankly, a heck of a long time to do something that Walmart was doing more than 20 years ago. Why the heck is it taking us so long?” Mike Drues“The gist of a UDI is to identify the specific product and manufacturer and potentially even the batch or lot or serial number of that product.” Jon Speer“This should not be a foreign concept to anybody. This is a concept of traceability - that’s all a UDI is - traceability.” Mike DruesLinks:FDA UDI Homepage: Unique Device Identification SystemCDRH Guidance: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) (July, 2021)FDA finalizes long-awaited UDI guidance (RAPS, July, 2021)Brazil’s new UDI requirements for medical devices: Compliance implications for manufacturersCode of Federal Regulations (CFR)FDA - 510(k) Submission ProcessFDA - Software as a Medical Device (SaMD)FDA - Premarket Approval (PMA)ABILIFYMike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

There are many schools of thought when it comes to the 'who, what, and when' of quality management for medical devices.In this episode of the Global Medical Device Podcast Jon Speer talks to Christie Johnson with Kasota Engineering, a consulting firm focused on quality in the medical device industry. Listen to this episode as Jon and Christie offer their insights and guidance on medical device quality management best practices.Some of the highlights of this episode include:Who manages quality? Most startups first hire someone with years of experience, but Christie encourages early firms to embrace the teach mentality. Christie enjoys training teams to build an understanding of quality from scratch.What is quality? Those with a willingness and capability to learn can be coached to know what a quality management system is and needs to include initially.Two Schools of Thought: Companies either view quality as, do it later when the time is right or that’s not my job. Quality is a way for companies to ensure safety and efficacy. Put your products and services at the center of your universe.Christie’s philosophy is to never do what traditional consultants in the industry do. She never just shows up, throws some documents down, and walks away.Which QMS to implement? The system that you should implement is the one that your team will use. Make it simple and fast. If your team cannot understand and readily use the tool, they’re not going to do it or follow the procedure/process.Delivering a QMS without providing step-by-step training can lose functionality. Start with baby steps into processes, especially for those without experience.What to include? You don’t need to comply with regulations right away. Put things in place - early data, suppliers - document/record what you’re doing during the research and discovery phase. Tell your story and take credit for your hard work.Why are you struggling? The reality is it takes longer than six months to one year to get your idea or product on the market. Trial knowledge can reduce risk.Memorable quotes from Christie Johnson:“If you can read and understand the regulation and if you can sit and work with me and help me understand your background and I can coach you, we can start putting in place your early quality system.”“Our philosophy is very much to never do what traditional consultants in the industry do, which is show up, throw some documents down, and walk away.”“The system that you should implement is the one that your team will use and make it easy.”“It’s really easy to get lost or just ignore the quality system that’s in place, especially if you come into an organization that already has way more than they need.”Links:Christie Johnson on LinkedInKasota EngineeringNational Institutes of Health (NIH) - Rapid Acceleration of Diagnostics (RADx)Devon Campbell with ProdctFDA - Medical DevicesISO 13485Meet a Guru - Taylor BrownGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What makes Greenlight Guru unique and sets it apart from other medical device solutions? It’s Guru edge⁠—a team of medical device professionals with a ton of industry experience.In this episode of the Global Medical Device Podcast Jon Speer talks to Maryann Mitchell, a Medical Device Guru and Solutions Engineer who has recently joined the Greenlight Guru team.Listen as Maryann shares fascinating details about her day-to-day working with device companies who are evaluating the Greenlight Guru Medical Device Success Platform (MDSP) to better understand their product and business needs and how Greenlight Guru's MDSP solution can help them achieve ultimate success.Some of the highlights of this episode include:Maryann’s background is in quality systems initiatives, and she has extensive experience with ISO 13485. She loves being a part of audits and truly enjoys defending quality systems.While Maryann has been through numerous ISO 13485 audits, she has experienced only a few FDA inspections. She explains that there’s a whole different level of terror when it comes to the FDA.Maryann was attracted to joining the Greenlight Guru team because of her interest in quality system software. She wanted to help the company sell its software and connect with customers and medical device companies.Maryann shares some of her favorite stories working with companies trying to evaluate their options for quality systems. The best part is customers’ positive reactions during design control matrix and risk matrix demonstrations.The benefits of Greenlight’s QMS include the ability to quickly and easily find and access visually appealing information and data. Ultimately, it helps people get through audits faster and be in compliance.However, Maryann explains how and why EU MDR continues to be a challenge for medical device companies. Compiling records and evidence for submission as well as interconnectivity are just some of the bigger quality issues.If the FDA transitions to the 13485 standard, Maryann believes the medical device industry shouldn’t panic but anticipate it. It would be better to have a harmonized way of auditing and inspecting companies.Memorable quotes from Maryann Mitchell:“I’ve lived and breathed the 13485, 820, all those fun standards, which I love. It’s really exciting and I love being in audits.”“There’s a whole different level of terror when it comes to the FDA, but it was really exciting to be there. Thankfully, I wasn’t in the hot seat for those, but I was in the front room to participate.”“Not just during an audit, but for your own internal quality, it’s just so much easier when your systems are connected, and that’s exactly what Greenlight offers to our customers.”“You should always be audit ready.”Links:Maryann Mitchell on LinkedInISO 13485 - Medical DevicesFDA InspectionsEuropean Union’s Medical Device Regulation (EU MDR)Meet a Guru - Sara AdamsMeet a Guru - Taylor BrownGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Medical device companies need to tell slightly different versions of their stories depending on the intended audience—investors, suppliers, regulators, clinicians, and patients—and each version must be strategically crafted and told in order to convey the right message.In this episode of the Global Medical Device Podcast Jon Speer talks to Brad Perriello, who previously cofounded MassDevice and now current founder and principal at Circle Hill Life Science Communications, about his unique line of work helping medical device companies learn how to effectively tell their story.Listen to this episode now to learn what your company can and can't say to different target audiences and how to effectively communicate your company’s core message and story so it positively resonates with the listener.Some of the highlights of this episode include:Brad Perriello, alongside fellow journalist Brian Johnson, founded the online medical device business journal MassDevice based on his belief that small businesses and startups drive everything that lead to the biggest outcomes.Although medical device companies know their story best, they do not always effectively tell people their story, what they do, and why they do what they do.Startups telling their story is applicable and important to raise funds, but engineers are not strong narrative writers or speakers. They tend to focus too much on details, which can derail the intended message.A medical device company’s core message and story is the same, but is communicated differently. For instance, investors want to know the ROI, patients want to know if it’s safe and effective, physicians want to know about safety, efficacy, and cost.When hiring outside help with communications, they should be familiar with the medical device industry because the regulatory environment is strictly unique. Be aware of quality systems, design controls, and reimbursement issues.Some things change over time, and some things never change. Find an unmet need and help patients and others by figuring out what they need to hear. Be able to effectively communicate with all audiences.Social media evolves quickly and provides powerful communications tools with massive reach. Companies succeed by having a dedicated team member who knows how to leverage each platform based on the audience.Memorable quotes from Brad Perriello:“These folks know their stories really, really well...but they don’t know how to tell them all the time.”“Through no fault of their own, they’re not really effectively telling people, this is our story, this is what we’re about, and this is why.”“The old adage is that engineers can’t write.”Links:Brad Perriello on LinkedInMassDeviceBrian Johnson of MassMEDIC on LinkedInMedtronicFDA - The Pre-submissionFDA - 510(k) Premarket NotificationGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Is your body becoming more frail? Are you worried about fractures? Do you want to improve your bone health? Osteopenia and osteoporosis are very common problems that don’t have completely effective solutions, yet.In this episode of the Global Medical Device Podcast, Jon Speer talks to Laura Yecies, CEO of Bone Health Technologies, about the product journey of OsteoBoost, a vibration belt that aims to prevent osteopenia and osteoporosis that has recently received the FDA’s Breakthrough Device Designation (BDD). Learn what the BDD experience was like and how their team is currently navigating the FDA regulatory process and collecting the necessary clinical data with the hopes of soon placing OsteoBoost on the US market.Some of the highlights of this episode include:More than 50 million Americans are suffering from osteopenia and low bone density. Half of all women will have a fracture from osteopenia and osteoporosis - that’s more than heart attack, stroke, and breast cancer combined.As people get older, especially women, shrinking is a real issue that is usually due to a fracture that causes pain as well as breathing and digestive problems.People with hip fractures have a 20-plus percent mortality rate. Hip fractures are difficult to recover from and a high percentage of people lose their independence.Currently, there are no approved treatments for osteopenia. Basically, your only options are to get enough Calcium and Vitamin D and do high-impact exercise. Give your bones enough stimulation to lessen the decline.There are medications for osteoporosis. However, the side effects, the way they work, and indications for use are for people with osteoporosis.When vs. If: Most people will eventually get osteopenia. Heredity is a factor that influences less dense and smaller bones. Lifestyle matters, such as excessive drinking and smoking or steroid use can have an impact on bone density.Also, if you are an astronaut or go into space, bone loss is accelerated. Evidence from NASA shows that using whole body vibration improves bone density.People must use such a device regularly, it is expensive, and it requires doing nothing for a period of time. Bone Health Technologies is developing OsteoBoost, a more practical and easy-to-use product that leverages whole body vibration.Memorable quotes from Laura Yecies:“Osteopenia is an incredibly common problem, and we have over 50 million Americans suffering from low bone density.”“If you walk around a nursing home, people are there typically for one of two reasons - they have Alzheimer’s or they have a hip fracture.”“Most people will eventually get it.”“There’s a body of evidence from NASA about using whole body vibration essentially to improve bone density. Astronauts lose a lot of bone when they are in space. Their bone loss is accelerated.”Links:Laura Yecies on LinkedInBone Health TechnologiesOsteoBoostU.S. Food and Drug Administration (FDA)FDA: Breakthrough Devices ProgramGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

FDA published a final rule, which goes into effect the first of September, to amend its “intended use” regulations.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the implications of FDA’s final rule on intended use, manufacturer’s objective intent, and the role that it has with labeling.Some of the highlights of this episode include:When Mike and Jon refer to labeling, they are talking about the content of the label - the words used and claims made.High-level labeling describes intended use, indications for use, and label claims. Low-level labeling includes directions for use and package inserts. A claim is a claim whether put in high- or low-level labeling.High- and low-level labeling can be leveraged as a strategic, competitive advantage to minimize or streamline regulatory burden, which means how much effort and evidence is needed to go through the FDA and put on the market.Intended use focuses on a device (what it does, how it works, and what is its mechanism of action). Indications for use focuses on the patient (what illness, injury, disease, or condition is the device intended to prevent, diagnose, or treat).Why do we need a new rule about intended use? The intended use rule is important for medical device manufacturers because labeling is not limited to what they say or print.The root cause for the rule relates to manufacturers’ saying or claiming one thing, but inferring and implying another thing. FDA does not regulate, at least not yet, the names of medical devices.Manufacturer's Objective Intent: If manufacturer knows or has knowledge of facts that product, device, or drug would be used for conditions or purposes other than what is advertised/claimed, manufacturer may need to provide adequate labeling.Manufacturers also need to consider product liability and reimbursement implications of a device being used for purposes other than what’s on the label.Memorable quotes from this episode:“When we refer to labeling, at least when I refer to it, I’m not talking about the sticky piece of paper that we stick on a package or in a box that a medical device comes in, nor am I talking about the graphics that go onto that label.” Mike Drues“There have been numerous and continues to be numerous warning letters, recalls, etc, etc, etc, that are strictly related to content or lack thereof or misinformation that’s on labeling.” Jon Speer“FDA does not regulate, at least not yet, the names of medical devices. So, you can embed a claim in the name of your device without it being subject, at least directly, to FDA regulation.” Mike Drues“Don’t just focus on what you say in your labeling, also consider what you don’t say and how you don’t say it.” Mike DruesLinks:FDA finalizes long-awaited intended use ruleFDA Delays Implementing Parts of 'Intended Use' RuleFederal Register’s Regulations Regarding “Intended Uses”FDA - Center for Devices and Radiological Health (CDRH)Mike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Have you ever thought about the versatility of an eQMS? As it turns out, the use of one medical device eQMS solution in particular is extending across multiple sectors.In this episode of the Global Medical Device Podcast, Jon Speer talks to Renee Rogge and Devin Hubbard, two academic professors/faculty members of biomedical engineering programs which are involved with the Greenlight Guru Academic Partner Program. Jon, Renee, and Devin discuss their work together in the program and Renee and Devin share their experiences using the eQMS from Greenlight Guru in the classroom and how it's helping students engage and better understand medical device risk and quality management concepts and practices.Some of the highlights of this episode include:Introducing Greenlight Guru to students has helped them to understand eQMS and how they can take the things they learn in theory and apply them in practice.Biomedical engineers need to be taught design principles, technical writing, and how to conduct tests and case studies with a risk matrix.Students should have a working knowledge and understanding of quality and regulatory affairs to prepare them for real-world application. The traditional approach to teaching risk in an engineer setting is to focus on failure modes and effects analysis (FMEA) and design failure modes and effects analysis (DFMEA). However, this singular approach is not efficient and can leave some medical device risks undetected, resulting in harm.Case studies should include ways to be reasonable, realistic, and helpful in product design and quality systems to think about how other options could fail.It is challenging in capstone design to deal with risk. Capstone courses are overwhelming for students and difficult to teach. Tackle risk in manageable way.Students don’t like doing busy work associated with quality management and risk assessments, but there’s a reason for it: ensuring the safety of people using a device you designed.Memorable quotes from this episode:“Using Greenlight in particular, introducing that to our students has really opened a lot of eyes and doors for our students at understanding what quality management systems look like and how they can take the things they are learning in theory and then apply them in practice.” Renee Rogge“There’s things that our students are getting out of an eQMS platform like Greenlight that they wouldn’t get if we were trying to do a paper-based system. There’s just subtleties and nuances that are built in that we don’t really have to teach. They can learn by experience.” Devin Hubbard“It’s not just a bunch of checkbox things they have to do. It’s critical for the development of the product that they communicate their ideas because someone’s going to pick it up and run with it later.” Renee Rogge“Risk is bigger than just a thing that you do as part of your design. It is a thing that drives your design.” Devin Hubbard“I think it’s easy to make risk boring. I think it’s hard to make risk engaging in a way that is educational for the students.” Devin HubbardLinks:Renee RoggeRose-Hulman Institute of TechnologyDevin HubbardUniversity of North Carolina/NC State - Joint Biomedical Engineering ProgramGuideWire PodcastFDA - Medical DevicesFDA - Design ControlsFDA - 510(k) Premarket NotificationISO 14971: Medical Devices - Application of Risk ManagementGuideWire PodcastGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

How efficient are your management reviews? Could improvements be made? It might be time to reevaluate and reconfigure your system processes to eliminate burdens and extract utmost value from these critical checkpoints while still satisfying compliance needs.In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, senior medical device guru at Greenlight Guru. Together, Taylor and Jon discuss the nuances of management reviews to help medical device managers and executives make better decisions for teams to achieve greater outcomes.Some of the highlights of this episode include:Learn the must-haves of management reviews, such as inputs, feedback, complaints, reporting, and audits during planned intervals, by following ISO 13485 and FDA 21 CFR Part 820 - Quality System Regulation.How often should management reviews be performed? The industry standard is once a year, but a lot could happen in 12 months. Greenlight Guru recommends management reviews twice a year, especially in the early parts of your business.Internal audits and management reviews are two activities that offer a snapshot in time of the overall picture of the health of your QMS. Then, the management review is a platform to escalate issues.Best practices for a management review include where more research, time, and effort should go. Don’t mistake a management meeting for a review. Pulling off a management review last minute is a lot easier than an internal audit.Your company’s key performance indicators (KPIs) and goals should be put on the agenda as a checkbox activity for the management review. Yet the list of topics/objectives should be discussed to assess how you handle your business.Document any decisions and actions to maintain the suitability, adequacy, and effectiveness of your QMS. In meeting minutes, include an action plan and product improvements related to customer requirements and correct problems.You can share your management review meeting minutes with notified body auditors, but not the FDA.If you have to hurry up and hustle to get data, is it reality data that you need? Is it that important? Automate, divide, and conquer.Memorable quotes from this episode:“The standard is pretty general on how often you should be doing management reviews.” Taylor Brown“Management review is really a platform to escalate issues.” Taylor Brown“Pulling off a management review last minute is a lot easier than trying to pull off all of your internal audits last minute.” Jon Speer“Executive management needs to be aware of and involved with the health of the quality system.” Jon SpeerLinks:ISO 13485 - Medical DevicesFDA - 21 CFR Part 820 Quality System (QS) RegulationTaylor Brown on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Guru Edge. It's what makes Greenlight Guru so unique and particularly valuable to medical device companies. These Gurus form an elite team of medical device experts who serve Greenlight Guru customers in a variety of ways to ensure success throughout their product journey.In this episode of the Global Medical Device Podcast, Jon Speer talks to Ryan Behringer, a Training and Onboarding Medical Device Guru at Greenlight Guru.Listen to this episode to learn about Ryan's professional journey which brought him to Greenlight Guru and how he's helping companies with design of experiments, design controls, contextual inquiry, FDA QSR and ISO 13485 compliance, protocol/report writing, protocol execution, and quality system implementation and maintenance.Some of the highlights of this episode include:Ryan studied biomedical engineering and eventually zoned and honed in on medical device entrepreneurship.After graduating from college, Ryan worked for a startup in Omaha that was a Greenlight Guru customer. Ryan was able to develop a device, get 510(k) clearance, and go to market using Greenlight Guru.Ryan’s first-hand experience with Greenlight Guru not only helped the development of the customer’s product, but boosted Ryan’s personal development as an engineer.To better prepare engineers, reduce the concepts to practice and teach design controls, quality, and regulatory curriculum.Ryan advises engineers to get the knowledge they need to be successful via a foundation of quality. Then, put into practice what you learn to be compliant.Risk Management/Design Controls: Always make sure you know why you are doing things. What’s the purpose? Find value in things and collect feedback.Ryan’s keys to customer success include using Greenlight Guru as a quality system and medical device platform to find early wins and deeper motivation.Memorable quotes by Ryan Behringer:“I love the entrepreneurship element in the medical device space.”“I had the pleasure of developing a device, getting  510(k) clearance, and getting to market utilizing Greenlight Guru. It was really instrumental in our development of the product and kind of my personal development as an engineer - gave me loads of confidence.”“I really enjoy the technical element of things.”“I always make sure that the things I’m doing, I know why I’m doing them. They have a purpose, and I can find value in those things.”Links:Ryan Behringer on LinkedIn21 CFR Part 820 (Quality System Regulation/Medical Device)ISO 13485 - Medical DevicesFDA - 510(k) ClearancesMedical Device HQGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Cybersecurity continues to be a crucial concern for medical device safety and effectiveness in the US, for manufacturers and regulators alike.In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues from Vascular Sciences about the opportunities and challenges associated with medical device cybersecurity. Listen as Mike and Jon share their thoughts on the potential ways to eliminate or reduce cyber threats and encourage better cybersecurity practices for medical devices.Some highlights of this episode include:Cybersecurity is an important topic, but why is the FDA concerned about it? It’s important not to over-generalize.For example, identity theft may involve a physical medical device or Software as a Medical Device (SaMD). With that, a person’s personal information such as their credit card number could be stolen. Should not be the FDA’s concern.What about patient privacy? Personal health information or confidential electronic health records are a HIPAA matter - not the FDA’s concern.Cybersecurity related to the safety and efficacy of a medical device, however, is the FDA’s concern.  Safety and efficacy of medical devices is part of FDA’s Center for Devices and Radiological Health (CDRH) mission.Some have seen in the popular press or been told the urban legend around cybersecurity concerns for implantable devices, such as insulin pumps, pacemakers, catheters, and angioplasty (a.k.a. the Johnny Carson Procedure).NIST’s call for position papers/statements covered five areas:Criteria for designating critical software.Initial list of secure software development lifecycle standards, best practices, and other acceptable guidelines.Guidelines outlining security measures that will be applied to the federal government’s use of critical software.Initial minimum requirements for testing software source code.Guidelines for software integrity chains and provenance.The categories above are not new and don’t really relate to cybersecurity. These should be standard operating procedures for companies developing products where cybersecurity and software is applicable.How to minimize or avoid cybersecurity concerns? Join boards/committees to create standards, and determine if there’s a legitimate reason to connect to the internet and communicate with the outside world.Memorable Quotes from this episode:“Safety and efficacy of medical devices is at least a paraphrase of part of the FDA - CDRH mission.” Jon Speer“If there’s a cybersecurity concern that could affect the safety of the device, that is something that FDA could and should be, quite frankly, concerned about.” Mike Drues“I’m a big fan of using regulatory logic.” Mike Drues“None of this is new. These should be standard operating procedures for companies that are developing products where cybersecurity and software is applicable.” Jon SpeerLinks:FDA lays out device cybersecurity efforts as feds look to implement Biden executive orderWorkshop and Call for Position Papers on Standards and Guidelines to Enhance Software Supply Chain SecurityResponse to NIST Workshop and Call for Position Papers on Standards and Guidelines to Enhance Software Supply Chain SecurityHealth Insurance Portability and Accountability Act (HIPAA)FDA - Center for Devices and Radiological Health (CDRH)U.S. Department of Health and Human Services (HHS)The Terrorist Hack that Shocked America – and Why it Matters (Homeland Episode)Johnny Carson Procedure (Angioplasty)Al GoreInternational Organization for Standardization (IOS)ASTM International - Standards WorldwideUnderwriters Laboratories (UL)Mike Drues of Vascular Sciences on LinkedInGlobal Medical Device Podcast, Episode 164: What is a multiple function device?Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru