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Times are Changing...

Ensuring compliance looks different depending on what phase you’re in (pre-market, post-market, or somewhere in between). That's why we're hosting a virtual summit with the primary goal of increasing your confidence in your journey through commercialization, no matter what product phase you are in. 

Day 1 - MAY 8


Focused on premarket complications and considerations including regulatory requirements for medical device design, risk management, building your team, and many other items that will give your team a clearer time to market and confidence in your quality systems competence.

How to Map Agile Processes for Medical Device Design Control Using SCRUMBAN Framework | 10:00 am EST

Speaker: Tanima Ghosh | Principal Medical Device Consultant at Enerxen Consulting Inc.

Mapping Agile processes for medical device design control using the SCRUMBAN framework involves adapting the principles of Agile development to meet the regulatory requirements for medical device design. The SCRUMBAN framework combines the best practices of Scrum and Kanban methodologies, allowing for flexibility in planning and execution while maintaining a focus on continuous improvement. This approach involves breaking down the development process into manageable tasks, implementing short development cycles, and prioritizing communication and collaboration among team members. By using the SCRUMBAN framework, medical device companies can achieve greater efficiency and adaptability in their development process while still adhering to the rigorous requirements for safety and quality in the medical device industry.

Winning Hearts, Changing Minds: How to Build a Risk-Aware Culture in Medtech | 11:00 am EST

Speaker: Christie Johnson | Partner at Prodct

Learn best practices for effectively communicating the importance of risk management to stakeholders in medtech companies. Discover how to engage and motivate the organization to embrace a culture of risk awareness throughout the product lifecycle. We will discuss practical strategies for overcoming resistance to change and building support for risk management initiatives.

Preparing a Device Master Record (DMR) | 12:00 pm EST

Speaker: Stephen Coulter, Ph.D. | General Manager at RCA

Anything worth doing, is worth doing right! Design Transfer helps manufacturers to reduce business risks. It ensures the company produces the right product with the right process and at the right price. The Device Master Record is the tool to ensure the right data has been provided for consistent and reliable production. Join us to learn how to prepare your DMF for a design transfer.

Talent Management Strategies: “Design Quality” for Commercialization | 1:00 pm EST

Speaker: Darwin Shurig | CEO & Founder at Shurig Solutions

First a company must understand the problem it’s trying to solve and will it matter to the market.  If so, what is the TAM and SAM?  After that the company must know it’s value proposition, the true benefit it brings to the market and establish a relevant mission statement.  Once the product has been properly designed and developed with strong compliance and risk management so that the product “blueprint” can produce safe, effective products for patients that are cost effective and financially sustainable then there must be a viable and efficient commercial launch strategy with ROI.

Identifying the obtainable addressable market, reimbursement, and payer access strategies, how much market share needs to be obtained for perceived success, marketing channels, sales strategies, increasing revenue in existing clients with improved account management, bringing in completely new clients……. There are several strategies and key considerations.

After knowing the desired goal, there is a lot of work needed to plan and execute.  Proper design and development of commercial launch strategies are critical, particularly post pandemic with increased opportunities for digital optimization, social media, and virtual opportunities for interaction.  If you don’t have the right people in the most optimal seats, the ability to execute goes down.

Talent Management Strategies: Design Controls for Commercial Launch Strategies will explore key considerations for commercial launch success in the world of the Metaverse while contemplating a blueprint for identifying talent to hire for attitude, cultural fit, and ability to grow tied to the Mission Statement that utilizes outcomes and analytics to creates best practices for attraction, efficiency and retention.

DAY 2 - MAY 9

Submissions & Clearance

Focused on offering solutions and insights into pre-market clinical studies, FDA vs EU requirements, and overcoming confusion around quality, regulatory, and clinical strategies.

Introducing Health Economics in Your Pre-Market Clinical Studies | 10:00 am EST

Speaker: Anders Mærkedahl | Partner at NHTA

Pall Johannesson | Managing Director at SMART-TRIAL by Greenlight Guru

This panel will explore the importance of incorporating health economic considerations into pre-market clinical studies for medical devices. Attendees will gain valuable insights into how health economics can be used to inform decision-making around pricing, reimbursement, and healthcare resource allocation, as well as learn best practices for incorporating health economics into their own pre-market clinical studies.

FDA vs EU Requirements: How Different or Similar are They Really? | 11:00 am EST

Speaker: Carolyn Algar Guthrie, MS RAC | Regulatory & Quality at Kapstone Medical

This webinar will discuss, from the industry side, the approach the Notified Bodies are taking during review of technical documentation and the quality management system during the CE certification process under MDR, and then discuss how this compares to recent FDA review and focus, as well as where they are going with the new QSMR.

Navigating Uncertainty: Quality, Regulatory & Clinical Strategies to Accelerate Medical Device Approval & Succeed in Value Based Healthcare | 12:00 pm EST

Speaker: Ruba Sarris Sawaya | CEO at MediStrat360 LLC


Scaling Manufacturing: 12 Key Questions | 1:00 pm EST

Speaker: Dan Purvis | CEO at Velentium

Join Velentium CEO Dan Purvis for a tour through twelve questions that must be answered before any medical device in development can be promoted from prototype to product. From design considerations like manufacturability and testability, through transfer to manufacturing, to the process, tools, facilities, cybersecurity, safety, and quality of manufacturing itself, Dan will walk you through what questions to ask at each step, and which answers will clear you to proceed.

DAY 3 - MAY 10


Focused on offering guidance and best practices for audits, manufacturing, and marketing your device to help companies with products on the market overcome challenges and strive for True Quality.

Unannounced Audits by Your Notified Body | 10:00 am EST

Speaker: Umesh Soni | Lead Auditor at TÜV SÜD

With the expertise on planning and conducting more than 200+ Unannounced Audit, Umesh will be presenting the history, background, and more details about the Unannounced Audits conducted by Notified Body.

Connecting Post-Market Studies with Your Commercial Strategy | 12:00 pm EST

Speaker: Wojciech Bobela, PhD RAC | Clinical Affairs Manager at Ziemer Opthalmics

Snorri Helgason | Director of Market Access at Nox Medical

In the highly regulated world of MedTech, it's crucial to strike a balance between patient safety and commercial success. This panel will explore the ways in which companies can effectively connect post-market studies with commercial strategy, with a focus on topics such as understanding the regulatory landscape, the importance of post-market studies, the role of commercial strategy in post-market studies, collaboration between regulatory and commercial teams, and trends and future directions.

Marketing Your Medical Device | 1:00 pm EST

Speaker: Mark DuVal | President & CEO at DuVal & Associates, PA

Come attend an overview of FDA’s regulation of medical device advertising and promotion taught by regulatory lawyer, Mark DuVal, J.D., FRAPS, who has over 36 years of experience both in-house at 3M Pharmaceuticals and three 3M medical device divisions, as well as at Medtronic, as head FDA and compliance lawyer, before starting his FDA law firm 21 years ago.  Mark will teach you about four buckets of communication and how to address advertising and promotion lawfully in each of them:

a) on-label promotion (what are claims and who can make them; knowing how to promote specific uses under a general intended use);

b) off-label dissemination and providing medical literature consistent with FDA-required labeling;

c) the broad communications bucket (which covers websites, social media, physician training, physician consultancies, CME and physician-initiated trials, Notices of Availability, etc.); and

d) the newest and most controversial category entitled off-label promotion established by case law, such as Caronia, Amarin, Pacira and the acquittals in U.S. vs Howard Root and Vascular Solutions. 

Mark’s presentation is designed to be practical and to help companies be appropriately aggressive, yet compliant, in their promotional efforts.

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This summit series will help you:

This summit will focus on commercializing and the ever-evolving journey that has many moving parts. This can mean something different to MedTech companies in different stages. What can you do to prepare for the regulations and the hurdles you might face?

Who should attend? 

  • Medical device executives
  • Leadership teams
  • Regulatory and Quality Professionals
  • Engineers 


Register Now  


Here are just a few of the industry experts that you can expect to hear from. Register now and be the first to know when new speakers are added.

Stephen Coulter, Ph.D.

General Manager - RCA

Stephen Coulter, Ph.D.

Dr. Stephen Coulter has areas of expertise in product development, design control, technology partnerships, product lifecycle management, and acquisition analysis. He is experienced in the development of manufacturing process controls and quality limits for critical product lines and has a global background in biomedical product, medical device, combination product, over-the-counter drug, consumer product, and environmental product companies ranging in size from startups to multi-billion dollar companies. He also successfully aligned development, quality, and compliance organization within a company to establish and sustain regulatory compliance to United States and International medical device regulations.

Christie Johnson

Partner - Prodct

Christie Johnson

Christie Johnson is a Partner at Prodct LLC, providing customized advisory and infrastructure development for early-stage medtech startups in Risk Management & Quality Management Systems. She also serves as Director of Quality at myBiometry, a digital health company focused on asthma management and is a content expert for the NIH's RADx program (accelerating COVID-19 diagnostics). Previously, as the founder of Kasota Engineering, she helped dozens of startups and small medtech companies establish tailored quality management systems and risk management files. Her diverse experience includes roles at industry-leading companies such as GE Aviation, Hologic, and Sonablate Corp.

Etienne Nichols

Medical Device Guru & Community Manager

Etienne Nichols

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.

Tanima Ghosh

Principal Medical Device Consultant - Enerxen Consulting Inc.

Tanima Ghosh

Tanima brings 30+ years of experience in Medical Device Management and Hardware/Software Product Development assisting highly regulated organizations to design, implement and maintain agile management systems that comply with international standards and best practices such as ISO 13485, MDSAP, 21CFR820, EUMDD/MDR, ISO 14971, IEC 62304, ISO 27001 and AS9100D.Tanima leads remediation activities, coaches front room audit preparation, performs supplier quality audits with inspection reports and prepares procedures, technical dossiers and 510(k) submissions. Tanima has successfully transformed development & implemented systems for different global clients including drug-device combination products, computer-assisted medical device surgical systems, microgravity payloads and space systems; telemedicine and expert systems, and platforms compliant with global medical device quality systems and international regulatory approvals. Tanima’s passion is building and leading “Dream Teams” for creative problem solving to unblock development, pre-audit playbooks, clear warning letters, qualify dual sources, obtain critical regulatory approvals, launch commercialization and support sustaining engineering/PMS activities using iterative agile hardware/software development best practices.

Páll Jóhannesson

Managing Director

Páll Jóhannesson

Páll Jóhannesson, M.Sc. in Medical Market Access, is the founder and Managing Director of SMART-TRIAL by Greenlight Guru. Páll was previously the CEO of SMART-TRIAL where he led the team to create the only EDC specifically made for medical devices.

Ruba Sarris Sawaya

CEO - MediStrat360 LLC

Ruba Sarris Sawaya

coming soon...

Wojciech Bobela, PhD RAC

Clinical Affairs Manager - Ziemer Opthalmics

Wojciech Bobela, PhD RAC

Wojciech is a Regulatory and Clinical Affairs Specialist with a strong scientific (MSc in Medical Biotechnology; PhD in Neurobiology), and Med-Tech consulting background. Throughout his career, Wojciech has been supporting both US and European medical device manufacturers, striving for compliance mainly with the requirements of the EU 2017/745 MDR. His clients ranged from small family companies, through startups to multi international corporations. Among others, Wojciech has been involved in establishment and management of Clinical Evaluation service delivery processes; provision of PMS/PMCF support; clinical/regulatory strategy definition and consulting,as well as delivery of numerous trainings and workshops.

Darwin Shurig

CEO & Founder - Shurig Solutions

Darwin Shurig

Darwin Shurig, CEO of Shurig Solutions, Inc, understands that people are the greatest asset at any company and the key qualities that growth companies need to grow market share while enhancing their positive culture and team environment.  He has a clinical background as a Respiratory Therapist of over 30 years including 12+ years of sales, business development, marketing and negotiations experience within medical device, diagnostics, distribution, ventilation, and sleep therapy, 8 years of sales leadership, 3 years of operations and extensive experience in negotiations and contract management before entering the entrepreneurial world of talent management.

He founded Shurig Solutions, Inc. in 2015 and is responsible for business development processes, contracting, and recruiting strategy, personally responsible for over $4 million in revenue generation while scaling a business that was paid $2.4 million in 2022 for the value it brings.  Darwin has created the SSI Educational Webinar Series, the SSI Executive Conversations Podcast, Candidate Prep Best Practices, and the TT Accelerant process.  Darwin was highlighted in the Creative Classics Book “The American Entrepreneur” published in 2020, was listed an MRI Top 10 Managing Partner for 2021, and SSI was ranked a Top 15 Office in 2022.  He has a heart for charity as SSI supports 4 independent charities and he is on the board of the MRI Charitable Foundation which supports Shriner’s Children’s Hospital.

Mark DuVal

President & CEO - DuVal & Associates, PA

Mark DuVal

Mark DuVal, J.D., is President & CEO of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry. Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council, The Food and Drug Law Institute and has been a former Chairman of the Minnesota State Food, Drug, and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs Services program at St. Cloud State University. Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters.

Carolyn Algar Guthrie, MS RAC

Regulatory & Quality - Kapstone Medical

Carolyn Algar Guthrie, MS RAC

Carolyn Guthrie serves as the Vice President of Regulatory Affairs and Quality Assurance for Kapstone Medical. She has been in the Medical Device industry in quality and regulatory functions for almost 20 years, working for and with both large corporations and start-up companies with a single employee. The types of devices she has worked with has varied from In Vitro Diagnostic devices to Orthopedic, Dental, Software, and Kitting, Packaging, & Sterilization devices. Carolyn has experience globally, with a focus on North America and Europe, in both the premarket and postmarket quality and regulatory functions, including premarket submissions (510(k) and CE Mark), as well as day-to-day operations in quality assurance and quality systems. Originally from South Africa, Carolyn is now based out of South Florida. She holds a BS in Biochemistry and Microbiology and an MS in Human Cell Biology from the University of Cape Town in South Africa and an MS in Regulatory Affairs (International) from Northeastern University in Boston, MA. In addition, she holds a RAC (Regulatory Affairs Professional Society Certification) for the US.

Umesh Soni

Lead Auditor - TÜV SÜD

Umesh Soni

Umesh Soni is currently leading the Unannounced Audit Program in TUV SUD America while supporting the special operations team as a “Senior Auditor”. He is also a Local Certification Reviewer, Technical File Reviewer and Lead Auditor for MDSAP, MDR, MDD, ISO 13485 and ISO 9001. He successfully led various process improvement and six sigma projects in TUV SUD. With 15+ years of healthcare industry experience, Umesh has areas of expertise in Auditing, Regulatory Compliance, Quality Engineering, Regulatory Affairs, Quality Systems, Product Life Cycle Management, Design Development, Manufacturing Process, Sustenance, Remediation, and Post Market. Umesh possesses graduate degrees in MBA in healthcare administration and MS in regulatory affairs. Umesh loves traveling and exploring new places.

Anders Mærkedahl

Partner - NHTA

Anders Mærkedahl

Anders Mærkedahl has 10+ years experience within MedTech market access and market dynamics. He has successfully introduced and driven access and sales strategies for both European and US markets. Prior to joining NHTA, Anders Mærkedahl was Global head of Health Economics & Market Access at Ambu A/S, where he established the global HEMA team and successfully integrated health economics and market access into product development (stage-gate model), clinical development plans, and launched excellence plans.

Dan Purvis

CEO - Velentium

Dan Purvis

Dan Purvis is the CEO and co-founder of Velentium, a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices. He is the coauthor of 28 Days to Save the World: Crafting Your Culture to be Ready for Anything.

Snorri Helgason

Director of Market Access - Nox Medical

Snorri Helgason

Snorri Helgason is the Director of Market Access at Nox Medical, a leading manufacturer of medical devices for sleep diagnosis. With a degree in Market Access from Aalborg University, Snorri has built a successful career in the healthcare industry, helping Nox Medical expand its reach and impact around the world. Today, Nox Medical sells its products in over 50 countries and has grown tremendously since it was founded in 2006.






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No matter what product phase you are in, this summit series will help you gain confidence and move along in the product journey.