Tiea is a quality and regulatory professional with experience in auditing, QMS, and medical writing relative to design and risk management. In her 20+ years of experience in the medical device industry, she has served in roles as project manager and design quality engineer. In these roles, Tiea acted as a change agent in QMS and DHF/DMR remediation efforts to resolve FDA 483 and notified body nonconformances for companies who were under warning letters or consent decree.

Tiea has performed 100+ audits as a Lead auditor for Notified Bodies to assess compliance with quality management system (QMS) standards (ISO 9001/13485) and regulatory requirements for the USA 21CFR820, EU (MDD/MDR, IVDD/IVDR), Canada (CMDCAS), and MDSAP jurisdictions (Australia-TGA, Brazil-Anvisa, Canada-CMDR, Japan-MHLW, and US-FDA). Tiea has experience with various technology types, such as, but not limited to software as a medical device, sterilization and sterile barrier systems, plastics, mechanical and electrical equipment and chemicals.

Based on these, Tiea is qualified for auditing most medical and IVD devices, with the exception of implantable devices. Tiea has working relationships with several private clients which required gap assessments and remediation activities of quality and regulatory documents relative to industry standards and country regulations.  

Andrew has almost 40 years of experience managing quality, design and development for large medical device companies, start-ups and contract manufacturers. He has proven expertise in quality systems, risk management, design controls, requirements management, software life cycle processes and reliability engineering. He has a proven track record for developing risk management processes and systems for software and hardware device using ISO 14971. He has leveraged this expertise to help companies improve compliance, product quality and reliability. He has a BS degree in Biology from Fort Lewis College, a master’s degree in engineering from Northwestern and a graduate certificate in Systems Engineering from University of Arizona.

Andrew is currently a Quality and Regulatory Consultant to the Medical Device Industry Specializing in Improving Quality Management Systems. His skills and expertise include:

· Medical Device Quality and Regulatory – FDA 21 CFR part 820, Quality Systems Regulations and ISO 13485 Quality Management Systems for Medical Devices.

· Recognized industry expert in Risk Management using ISO 14971 and including integration with t=requirements for IEC 60601 and IEC 62304.

· Requirements lifecycle management including eliciting/formulating requirements, traceability and configuration management across the lifecycle.

· Design Verification, Design Validation planning and execution

· Process development, characterization and validation planning and execution.

· Supplier quality management and purchasing controls.

Samir Paliwal is Sr. Director for Quality at PerkinElmer, an Environmental, Food and Human Health company. Prior to joining PerkinElmer, he worked at Allergan, CR Bard and Covidien (now Medtronic) holding various positions in Quality and Operations. He has over 20 years of experience in the industry and has held positions primarily in Quality Assurance, and also in Product Development, Operations and Regulatory Affairs. His work experience includes development and management of quality systems, new product development and launch, post market surveillance, risk management, supplier management, and due diligence assessments to support acquisitions.

 

David has a background in Software Engineering and has 26+ years of experience developing and validating Medical Devices. He currently is an Associate Software Director for Boston Scientific Neuromodulation.  His responsibilities include managing all aspects of software development and validation including security risk.  In addition, David is a faculty member at AAMI and has been developing and instructing courses for more than 12 years.

Eric Kruschke has a three-decade background in medical devices spanning R&D, Process Development, and Manufacturing.  He currently is a Senior Manager in Process Development at Boston Scientific specializing in new-product development. His role centers primarily on interventional oncology tools for catheter labs, but he has supported projects in many divisions across new products, transfers and acquisitions.  He's been an AAMI (Advancement of Medical Instrumentation) instructor supporting Design Controls and Process Validation since 2021. Eric has a BS in Mechanical Engineering from SDSM&T. 

Dr. Peter Knepell is the President of Peak Quality Services. He is a Certified Master Black Belt (MBB), Certified Quality Engineer (CQE), and Certified Software Quality Engineer (CSQE). He has broad industry experience helping firms adopt Lean Six Sigma quality systems and meet FDA-regulatory requirements. In the mid-1990s, Pete assisted the FDA with the introduction of their Quality System Regulation. Pete has presented over 30 webinars and is on AAMI’s faculty for: Valid Statistical Techniques, Design of Experiments, and Process Validation. 

Jack Ward is a recognized quality assurance and regulatory affairs professional with over 40 years’ experience in the medical device industry. Jack has held a broad range of corporate management, engineering and Quality/Regulatory positions with direct experience across a broad range of medical device types, technologies and applications. Jack’s company, Ward Sciences and Consulting LLC, provides consulting expertise to medical device companies for regulatory submissions, Quality Management System implementations and audits, remediations and training. 

Pablo is a quality leader partner to support business top-line goals and challenge financial drivers. Focus on the Quality Systems including External & Internal Audits, Design Controls, Risk Management, Human Factors and Post Market Surveillance within my organization to implement a newly designed Risk Management process that is scalable to serve a variety of product complexities for the business while meeting the highest level of compliance and best practices to EN ISO 14971:2019 and Europe’s Regulations (EU MDR and IVDR). 

During his career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions for major medical device companies, including a period as Corporate Director of Risk Management.   He has over 39 years’ experience in the field of quality and regulatory affairs, including time as Director of Quality and Regulatory concurrently for four US sites.  Currently he consults and provides training in the area of medical device quality, regulatory and risk management. With Stan Mastrangelo, he co-edited Lifecycle Risk Management for Healthcare Products: From Research Through Disposal published by PDA and has written extensively in the area of quality, regulatory, and risk management for medical devices and combination products. 

ASQ has awarded Mr. Bills with Fellow status as well as Certified Quality Engineer, Certified Quality Auditor, Certified Manager of Quality and Organizational Excellence, and he is  Regulatory Affairs Certified by the Regulatory Affairs Professionals Society. In his career he has given presentations nationally and internationally in the field of quality management and risk management.   

Additionally, Mr. Bills serves in international standards work, assisted in completing the revision of the third edition of ISO 14971 risk management standard and the guidance ISO TR 24971:2020 as an international member of the technical committee.   He also serves on the US national committee for the medical devices quality system standard, ISO 13485, as well as the medical bed standards, IEC 60601-2-52, IEC 60601-2-89, and the AAMI technical committee CP contributing to the combination products risk management guidance, AAMI TIR 105.  

Mr. Bills has recently taught as part of the Quality Science Education program at The Wistar Institute, and LaSalle University under the Pathways for Patient Health program.  He has previously taught at University of Southern California, the University of Washington, and Purdue University Southeast.  He was also adjunct faculty at Virginia Tech in the Health Products Risk Management Graduate Program and assisted in development of that program. 

Recently, Mr. Bills joined Gessnet as a Technical Advisor.  He also serves on the Advisory Board of Product. 

Annette Hillring has been an independent regulatory affairs consultant since 1998. Prior to consulting, she worked in the medical device industry with ophthalmic, cardiovascular and general hospital devices. She has over 40 years of experience in regulatory affairs, quality systems, clinical affairs and compliance. Her worldwide regulatory affairs responsibilities have included FDA and worldwide device submissions, Quality System Regulation compliance, ISO 13485 conformance, interpretation of all FDA regulations and policies, regulatory representation on new product development teams, due diligence assessments and product liability. She has also served as an expert witness for FDA and has extensive experience in software related FDA/industry guidance and standards-setting activities.

Ms. Hillring is Regulatory Affairs Certified and holds BA degrees in biology, microbiology and secondary science education

Mr. Mark Walker is a consultant and owner of Walker Validation and Compliance Services located in Southwest Florida.  Walker Validation and Compliance Services (WVCS) provides consulting services to Medical Device, Pharma and Biotech industries involving FDA's Quality System Regulation and ISO Quality Management system (ISO 13485).  Mr. Walker’s industry experience includes, IVD, cardiovascular, orthopedics, plasma collection and processing, surgical devices, convenience kits, various medical device software manufactures, OTC drug manufacturing, bulk drug manufacturing, and large biotech.  Services include regulatory compliance, computer systems validation, medical device software development life cycle, software and production equipment qualification, quality management system (QMS) auditing, QMS development, QMS training, risk management, and 21 CFR Part 11 compliance (Electronic Records and Electronic Signatures).  Mr. Walker has more than 25 years of experience in providing project management, consulting, training, regulatory compliance and business development services.
Mr. Walker has been an instructor for the Association for the Advancement of Medical Instrumentation (AAMI) since 2012 which develops training and guidance with FDA for the use of medical devices.  He currently serves on AAMI Medical Device Software Committee.  Mr. Walker was a contributing author for The Quality System Compendium: CGMP Requirements and Industry Practice, Fourth Edition and also co-authored “Risk Management Tools” (Chapter 2) in the book “Risk Management Applications in Pharmaceutical and Biological Products Manufacturing”, published by John Wiley & Sons, Inc.
Mr. Walker has a Bachelor of Science degree and an Associate of Engineering degree in chemical engineering technology.  In his free time, he volunteers with county emergency rescue service agencies providing technical rescue, emergency medical services and computer systems support.

With over 17 years of experience in both consulting and FDA regulatory review evaluations, QuynhNhu Nguyen is the Director of Human Factors and Regulatory Strategy (HURAS) at Kymanox.

QuynhNhu has over 15 years of FDA regulatory science and evaluation experience with human factors, medication errors, and product design and development, reviewing 900+ medical products (devices, drugs, biologics, and combination products) that covered all therapeutic areas from various phases starting with investigational product applications to marketing applications to post approval supplements.

QuynhNhu has about 2 years of HF regulatory consulting with Kymanox and has supported 45+ projects serving small, medium, and large pharmaceutical companies in ensuring comprehensive HF program executions with data-driven regulatory strategies and “Right First Time” submissions.

QuynhNhu earned a Master of Science Degree in Systems Engineering from Johns Hopkins University and a Bachelor’s degree in Biomedical Engineering from George Washington University.

 

Rita has effectively managed medical device designs from concept to commercialization. She applies her technical and regulatory backgrounds to coordinate teams across multiple disciplines and departments. Rita has successfully led efforts to develop new digital health products while at Vigor Health, execute design modifications on spine devices while at Stryker, and help clear and approve hundreds of medical devices and combination products while at the FDA.

During her career, Rita has earned several certifications and awards, including the Stryker Innovation award, FDA Quarterly awards, Six Sigma Green Belt, and RAC. She is also expert faculty for the AAMI Human Factors for Medical Devices and 510k/De Novo training courses, and is a recurring speaker for the Human Factors and Ergonomics Society and Clemson University College of Engineering.

Rita graduated from Duke University with a Bachelor’s and Master’s degree in Biomedical Engineering.

Ed Israelski is a consultant and the retired director of Human Factors at AbbVie, a biopharmaceutical company. Ed’s consulting practice focuses on giving strategic advice to medical product clients to ensure compliance with US FDA and international standards to achieve regulatory approval. He joined AbbVie (Abbott Labs) in 2001, where he led a cross-company team to imbed best-practice human factors engineering HFE design methods into all of AbbVie’s products, to ensure safety and usability. He did this through hands-on design and evaluation of key new products, building and managing a group of HF professionals; training and mentoring internal resources, writing corporate policy and guidelines and facilitating the use of outside professional HFE resources. For these efforts he was awarded a Lifetime Achievement Award from the AbbVie Volwiler Society.

Melissa Lemke is the founder and Principal Human Factors Engineering and Accessibility Advisor with Human Ability Designs, a human factors consultancy that supports client organizations in achieving human factors regulatory success and meeting user interface optimization goals throughout the pre-market and post-market design process. Melissa is dedicated to helping clients develop and bring to market medical products that are safe, effective, and usable for people of all abilities through applying sound human factors engineering strategies and methods.

 Melissa is a Biomedical Engineer with over 20 years of experience designing successful human factors regulatory strategies, leading cross functional teams, and executing human factors analyses of medical devices, combination products, training and labeling. She also is a lay caregiver for her brother with spinal cord injury.

 Formerly, Melissa built and managed the human factors services of Agilis Consulting Group, managed the Accessibility and Usability Testing Laboratory at Marquette University, and was a researcher and instructor with the University of Wisconsin at Milwaukee.

 Melissa is an active member of the Human Factors and Ergonomics Society (HFES) as well as the Association for the Advancement of Medical Instrumentation (AAMI). She serves on AAMI’s Human Factors Engineering and Home Care and EMS Environments Committees. She is a contributing author to the original HE75: Human Factors Engineering - Design of Medical Devices, including lead co-author of the accessibility considerations section. More recently, Melissa led the committee updates of the revised HE75 for the sections on Accessibility and Devices Used in Non-clinical Environments by Laypersons and contributed to human factors industry publications including, Applied Human Factors in Medical Device Design (2019) and Development of Biopharmaceutical Drug-Device Products (2020).

Tressa has shared her 24 years of experience in Human Factors Engineering in both regulated and non-regulated industries.  Currently Tressa is the Sr. Director, Global Human Factors and Usability Engineering at Teleflex.   She contributes to industry by teaching the AAMI Human Factors in Medical Device Design course, serving on the AAMI Human Factors Engineering Standards Committee as well as hosting regular webinars for both AAMI and outside the US organizations focused on medical device design and development.    Tressa holds a Master’s in Human Factors Engineering and Applied Experimental Psychology and a Bachelor’s degree in psychology and is based in San Diego California. 

Deborah Havlik has been working as an independent consultant with expertise in microbiology and sterilization for the past four years.  Prior to that, she was the Director of R&D Microbiology for a major pharmaceutical company and was responsible for supporting the development of microbiological test methods and sterilization processes for drug products, biologics and combination products globally. Deborah has industry experience working in medical device, contract sterilization/contract laboratory and pharmaceutical companies. She has developed sterilization processes in ethylene oxide, moist heat, dry heat and radiation and also evaluated novel sterilization technologies. She is active with the Parenteral Drug Association and with AAMI and ISO on multiple working groups developing sterilization standards, and is a member of the USP Small Molecules 1 Expert Committee.  

Kevin is the Director of Radiation Physics at Sterigenics with corporate responsibility for measurement and calculation of absorbed dose associated with the radiation treatment of product, such as sterilization of healthcare instruments. Kevin holds almost 30 years of experience in radiation physics and radiation dosimetry within a highly technical industry. He is actively involved in numerous industry committees, task forces and working groups. As a Working Group Member, Kevin represents Canada on ISO TC 198 WG2 Radiation Sterilization. He is also a member of the AAMI Sterilization Standards Committee, WG2 – Radiation Sterilization; ASTM Subcommittee E61 Dosimetry for Radiation Processing; and Chair or Co-chair of ISO/ASTM 51707 Estimating Uncertainties, 51275 Radiochromic Film, E2232 Mathematical Methods. Kevin is a Former President/VP, Radiation Process Simulation and Modelling User Group (2002 – 2010). Over his career, Kevin has been published many times.

Expertise: Radiation Sterilization Expert, Radiation Dosimetry, Mathematical Modelling, Hockey

Publications

“A Comparison of Gamma, E-beam, X-ray and Ethylene Oxide Technologies for the Industrial Sterilization of Medical Devices and Healthcare Products,” published by Gamma Industry Processing Alliance (GIPA) and International Irradiation Association (iia), 2017

Chapter on Gamma Technology, in “Food Irradiation Research and Technology, Chapter: Dosimetry for Food Processing and Research Applications, IFT Press, Blackwell Publishing, 2nd Edition, 2014

“Evaluation of Tracers and Contrast Agents in Optical Molecular Imaging,” a compilation of numerous publications and the potential impact on Medical Isotopes, 2009.

Biological safety in the context of backward planetary protection and Mars Sample Return: conclusions from the Sterilization Working Group, International Journal of Astrobiology, External Subject Matter Expert (2021)

Clark Houghtling is the Vice President of Business Development & Technical Affairs for Cosmed Group, Inc. Cosmed was founded in 1981 to sterilize medical devices and spices. The company grew to be among the largest contract sterilization companies in the United States, until it divested its five medical device sterilization locations in 2005 to focus on food safety. The company continues to use various technologies to pasteurize raw agricultural commodities in facilities dedicated to those purposes. The company reentered the medical device sterilization market in 2012 performing contract sterilization, along with selling sterilization equipment (i.e. sterilizers, control systems, scrubbers, and related accessories).

Clark’s varied background includes extensive knowledge in sterilization technologies, related microbiological and chemical testing, business development, plant and quality management, medical device manufacturing, sales, marketing, and regulatory affairs. Prior to this position, Clark worked in various upper management positions for companies including Comet ebeam Technologies, Synergy Health, Stryker Orthopaedics, Microtest Labs, Steris, Mallinckrodt, and Ethox.  He holds a Bachelor of Science degree in Biology from the State University of New York at Geneseo, and attended graduate school in Biology at Niagara University. 

Clark has taught many courses and is a frequent lecturer to many varied groups including the Food and Drug Administration (FDA), the Association for the Advancement of Medical Instrumentation (AAMI) (where he is an AAMI Fellow and serves as an instructor for the Industrial Sterilization for Medical Devices and the Industrial Ethylene Oxide Sterilization for Medical Device courses), the International Society for Pharmaceutical Engineers (ISPE), the Center for Professional Advancement (CPA), and for various companies.  He is a member of the Sterilization Standards Committee at AAMI, the American Society for Microbiology (ASM), and a senior member of the American Society for Quality (ASQ). In addition, he served as Vice President, and as Treasurer, of the Ethylene Oxide Sterilization Association (EOSA), and is a former ASQ Certified Quality Auditor (CQA).  Clark also participated in helping formulate the AAMI Certified Industrial Sterilization Specialist (CISS) program, and was in the first group to achieve the CISS certification in Ethylene Oxide, Radiation, and Moist Heat. 

David has a background in Software Engineering and has 26+ years of experience developing and validating Medical Devices. He currently is an Associate Software Director for Boston Scientific Neuromodulation.  His responsibilities include managing all aspects of software development and validation including security risk.  In addition, David is a faculty member at AAMI and has been developing and instructing courses for more than 12 years.

Jeremy Jensen is a Fellow Software Quality Engineer in the corporate global software steward group of Boston Scientific. Currently he responsible for establishing and maintaining effective structures to ensure consistent implementation of quality systems as it relates to regulated software at Boston Scientific. He helps create and implement processes and process improvements to ensure consistent implementation of external regulated software laws, regulations, guidance’s and standards (LRGS).

Mike Russell is a Partner with SoftwareCPR®. He provides services such as Quality Management System assessments and efficiencies, regulatory filing assistance, development process improvements, and leadership coaching and training. He is an expert in business agility and “agile and compliant” process transformation. Mike served on the TIR working group that created the AAMI TIR45- 2012 Technical Information Report Guidance on the use of Agile practices in the development of medical device software. 

Mike combines expertise serving as both a C-level executive, including as Chief Operations Officer for a top 60 U.S. bank, and as a trusted advisor to CEOs and other top leaders at diverse organizations in multiple industries. This has provided him with first-hand experience dealing with many opportunities and challenges facing leaders today, especially with rapid change and digital transformation. For example, while leading a product division, Mike introduced changes that resulted in improved productivity by 15%, cut time-to-market by up to 67%, and reduced defects by over 50% in flagship products processing of over $80 billion in financial transactions per year.

His experiences cover 48 U.S. states, Puerto Rico, U.S. Virgin Islands, and 20+ countries. He has spoken internationally and written on many subjects, including transformation and business agility, in his book Wrong Until Right – How to Succeed Despite Relentless Change. He also has been a reviewer for other authors’ books and publications. He has taught at both undergraduate and graduate levels and was a Lean Startup Week mentor.

Mr. Mark Walker is a consultant and owner of Walker Validation and Compliance Services located in Southwest Florida.  Walker Validation and Compliance Services (WVCS) provides consulting services to Medical Device, Pharma and Biotech industries involving FDA's Quality System Regulation and ISO Quality Management system (ISO 13485).  Mr. Walker’s industry experience includes, IVD, cardiovascular, orthopedics, plasma collection and processing, surgical devices, convenience kits, various medical device software manufactures, OTC drug manufacturing, bulk drug manufacturing, and large biotech.  Services include regulatory compliance, computer systems validation, medical device software development life cycle, software and production equipment qualification, quality management system (QMS) auditing, QMS development, QMS training, risk management, and 21 CFR Part 11 compliance (Electronic Records and Electronic Signatures).  Mr. Walker has more than 25 years of experience in providing project management, consulting, training, regulatory compliance and business development services.
Mr. Walker has been an instructor for the Association for the Advancement of Medical Instrumentation (AAMI) since 2012 which develops training and guidance with FDA for the use of medical devices.  He currently serves on AAMI Medical Device Software Committee.  Mr. Walker was a contributing author for The Quality System Compendium: CGMP Requirements and Industry Practice, Fourth Edition and also co-authored “Risk Management Tools” (Chapter 2) in the book “Risk Management Applications in Pharmaceutical and Biological Products Manufacturing”, published by John Wiley & Sons, Inc.
Mr. Walker has a Bachelor of Science degree and an Associate of Engineering degree in chemical engineering technology.  In his free time, he volunteers with county emergency rescue service agencies providing technical rescue, emergency medical services and computer systems support.

Jeff Ruiz CHTM, is a Senior Site Manager with Trimedx serving Sparrow Health System and Holland Hospital. Jeff also serves as a member of the Editorial Advisory Board with 24x7 Magazine and has 

authored numerous articles for the magazine. Jeff is also a member of the AAMI Faculty supporting the CHTM Study Group. Jeff received his ACI CHTM certification in 2018. He has Associate’s Degree in 

Electrical and Biomedical Engineering Technology as well as a Bachelor’s in Quality Management. Long Form Bio: 

Jeff Ruiz, CHTM is a Senior Site Manager with Trimedx serving Sparrow Health System and Holland Hospital. Jeff has been with the Trimedx organization since 2010. Jeff was the winner of Trimedx’s Making a Difference Value aware in 2019. Jeff also helped led his Holland Team as Trimedx’s HCT Best Site in 2019. Jeff serves as a member of the Editorial Advisory Board at 24x7 Magazine as well as contributing author. Jeff is a member of AAMI’s faculty supporting the CHTM study group. Jeff was a contributing member of the CHTM exam review in 2019. 

Prior to Trimedx, Jeff worked for Home Care of Michigan as Director of Operations. Jeff has been in the Healthcare Industry since 1985. Jeff was also Adjunct instructor at Muskegon Community College from 2017 to 2022 for Biomedical Instrumentation. Jeff was able to update the program which included expanding the program from one semester course to two. 

Jeff has earned an Associates in Electric Engineering Technology from Lawrence Technical University, Associates in Biomedical Engineering Technology from Schoolcraft College, and a Bachelor’s Degree in Quality Management from the National Graduate School of Quality Management. Jeff has received his ACI CHTM certification in 2018. 

•Been a HTM professional for over 40 years 

•Has taught the CBET (Certified Biomedical Equipment Technician) Review Course since 2020 

•Graduated with a bachelor's from Kaplan University in 2010 

•CBET since 2006 and CHTM since 2016. 

•Had Held Biomed, Lead Biomed, Customer Quality Manager, CBET and Sr. Manager roles throughout my career but my heart and soul are being a Biomed (especially in the OR). 

•Current Role is Technical Training Manager for Renovo Solutions 

•Previously worked at Stanford Health Care, GE Healthcare and UCSF. 

As a seasoned Leader with over 23 years of experience and a Vice President of Quality & Regulatory, Pooja drives excellence in Medical Technologies, including digital health and combination products. Her expertise lies in building strong teams, coaching and mentoring teams to excel, negotiations, and alignments with stakeholders including regulatory bodies worldwide, global quality & regulatory strategy, regulatory compliance, risk management, software design quality and post-market surveillance.

With a hands-on approach, she has established quality systems based on FDA QSR (device and combination products), EU MDR/IVDR, EU MDD, ISO 13485 and MDSAP for class 1, class 2, and class 3 medical devices, strategized and lead FDA inspections, and global audits, lead teams conducting design quality activities, digital applications program portfolio management, product quality activities, CAPAs, recalls, management reviews, led remediation strategies and execution post FDA inspection/notifying body audits, and guided stakeholders through global regulatory and compliance.

Rob Packard is the founder and President of Medical  Device Academy—a full-service quality and regulatory consulting firm with 12 employees. Rob earned his degree in Chemical Engineering from the University of Connecticut @ Storrs. Prior to Medical Device Academy, Rob worked for 10 years in the pharmaceutical and biotechnology industry in research and development of new drug products and biologics.

Jack Ward is a recognized quality assurance and regulatory affairs professional with over 40 years’ experience in the medical device industry. Jack has held a broad range of corporate management, engineering and Quality/Regulatory positions with direct experience across a broad range of medical device types, technologies and applications. Jack’s company, Ward Sciences and Consulting LLC, provides consulting expertise to medical device companies for regulatory submissions, Quality Management System implementations and audits, remediations and training.