Global Medical Device Podcast powered by Greenlight 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

Many medical device companies experience challenges with managing clinical trials even in the most ideal settings, so what happens when big changes occur, like COVID-19 and new regulations, that compound those challenges? If only there was a solution...In this episode of the Global Medical Device Podcast, Jon Speer talks to Pall Johannesson, CEO and co-founder of Smart-Trial – a digital platform that helps medical device companies manage many, if not all, clinical data activities.Listen to Pall’s story about his solution for managing clinical trials, which has many similarities to that of Greenlight Guru, as he discusses his vision and the problem they're attempting to solve to help manufacturers, as well as patients, save time and money with clinical trial management.Some highlights of this episode include:Pall started Smart-Trial as a solution to solve the problem of the medical device industry being underserved. The technology being used to generate clinical evidence and collecting clinical data in clinical studies was outdated.Smart-Trial empowers medical device manufacturers to be in control of their own clinical evidence. Data is becoming more valuable, so companies need to control and access their own data. EU MDR has increased the need for clinical evidence and ongoing clinical data for products. Pall discusses how some companies adopt and adapt to it by taking advantage of collecting data and clinical evidence early on and doing it well.Pall describes similar challenges in the United States and EU. The MDR has pushed companies toward the United States as far as where to start with your market access and different directions to develop clinical evidence.  Smart-Trial’s products and services streamline the clinical side of things. Pall works with startups to well-established corporate medical device companies. However, the complexity of the device comes with complexity of the studies. Pall agrees that the medical device industry is moving toward integration of AI, machine learning, and other intelligent technology. It’s better to find experienced partners to make smart decisions that benefit manufacturers and patients.A big mistake made by medical device companies is collecting too much data. Start small and be specific. One of the best practices is to involve analysis of clinical evidence by a statistician.  Memorable quotes from Pall Johannesson:“The technology that they were using for generating clinical evidence or basically collecting clinical data in clinical studies was outdated by far.”“We empower medical device manufacturers to be in control of their own clinical evidence. Data is becoming more and more valuable.”“Medical device companies, today and in the future, will have to rely much more on having control and access to their own data.”“The biggest impact is definitely companies that wait too long.”Links:Pall Johannesson - LinkedInSmart TrialEuropean Union - Medical Device Regulation (EU MDR)U.S. Food and Drug Administration (FDA)FDA - 510(k) Premarket NotificationHalo by Greenlight GuruGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What is the role of the importer, according to EU MDR? The requirements for this role have changed since the new regulation went into effect in May 2021 and it's important to understand the extent and impact of these changes.In this episode of the Global Medical Device Podcast, Jon Speer talks to René Van De Zande with MedEnvoy Global, a specialty solution for European regulatory compliance that offers importer representation services. In addition, René founded EMERGO in 1997, later becoming what's known today as EMERGO by UL.Listen to this episode as Jon and René discuss expectations, criteria, and obligations for importers under EU MDR and how this role should be managed for post-market surveillance, tracking, labeling, translations, and complaints.Some highlights of this episode include:Only two economic operators can be held responsible for placing a device on the market - a legal manufacturer that resides in the European Union or an importer.EU MDR does not clearly define who is who in the supply chain when it comes to economic operators. Articles 11, 13, and 14 overlap activities, obligations, and responsibilities for authorized representatives, importers, and distributors.According to René, there are three kinds of distributors: 1. Takes on the role of importer, as well; 2. Capable of taking on the importer role; and 3. Refuses to take on extra liability as the importer.Conduct proper due diligence when selecting an importer. First, map out who is who within your supply chain. Are there multiple distributors with quality agreements in place? Are obligations properly addressed to be met?Importers and/or distributors should have a quality management system (QMS) that complies with ISO 13485 and MDR to fulfill obligations.Person Responsible for Regulatory Compliance (PRRC) and importers are definitely different. PRRC is within an organization, and importers are outside representatives hired to provide services.Memorable Quotes from René Van De Zande:“It’s here, and it’s here to stay. There are no delays - at least not for the MDR. Since May 26, it’s alive and kicking.”“The role of the importer is a critical one because there are only two of the economic operators that can be held responsible for placing a device on the market.”“The MDR has not clearly defined who is who in the supply chain when it comes to economic operators.”“You need to do proper due diligence. First, you need to map out as a company, who is who within your supply chain.”Links:René Van De Zande on LinkedInMedEnvoy GlobalEmergoUnderwriters Laboratories (UL)European Union - Medical Device Regulation (EU MDR)Economic Operators Guidance DocumentMedical Devices Directive (MDD)EU In-Vitro Diagnostics Regulation (IVDR)ISO 13485Mutual Recognition Agreement (MRA) for Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can use to guide product development and marketing submission planning. There is an art to preparing a Pre-submission, though, so it's important to include the necessary contents (and avoid common pitfalls) that will yield the best possible results.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about Pre-submissions. Listen as the two share recommendations about what content to include in a Pre-sub request to FDA as well as costly pitfalls to avoid with this particular Q-submission type.Some highlights of this episode include:A Pre-submission meeting is an opportunity to communicate with FDA prior to a marketing submission.About 3,306 medical device-related Pre-submission requests were made to FDA in 2020. In 2021, more than 1,500 Pre-submission requests have been made so far.Not all Pre-submission requests are made for meetings with FDA. About two-thirds of Pre-subs requested a meeting and one-third requested written email communication only.On average, FDA takes two months to give a written response of approval or denial for a Pre-submission request.A Pre-submission is completely optional and never required, but highly recommended.The only time that Mike does not recommend a Pre-sub is when the marketing submission is a ‘slam dunk’ in terms of the agency's decision. That rarely seems to occur, especially because 75% of 510(k)s and 89% of PMAs are rejected the first time.Unlike 510(k) and PMA submissions, as well as 513(g) requests for information, there is no user fee associated with Pre-submissions.When crafting a Pre-submission, justify reasons for why certain approaches are being taken over others.Memorable Quotes from Mike Drues:“A Pre-submission meeting is an opportunity to talk to the FDA before you actually make your submission.”“Clearly, the popularity of the program is increasing.”“A Pre-sub is purely optional. It is never required. A company can choose to do a Pre-sub or not.” “Unlike 510(k) and PMA submissions, unlike 513(g) requests, and so on, there is no user fee associated with the Pre-sub—although at least not yet.”Links:FDA - Q-Submission Guidance - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission ProgramFDA - Premarket Notification 510(k)FDA - Premarket Approval (PMA)FDA - De Novo ProgramFDA - 513(g) Requests for InformationFDA - Medical Device User Fee Amendments (MDUFA) ReportsFDA - Center for Devices and Radiological Health (CDRH)FDA - Medical Device OverviewMike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru