FDA Regulatory and Clinical Services for the Medical Technology Industry

Our Staff

Marie Marlow | CEO, Senior Project Manager II

Marie has worked in the medical device industry for over 30 years; she founded M Squared Associates in 2001. She particularly enjoys working with clients and her M Squared colleagues to develop and refine regulatory strategies that support clients' business strategies. She has managed many successful Premarket Approval Applications (PMAs), presented PMAs and reclassification petitions before FDA Medical Device Panels, guided de novo 510(k) submissions and 513(g) requests for classification information to favorable outcomes, and helped clients appeal FDA regulatory determinations. She works with the M Squared teams that develop Investigational Plans for premarket and postmarket studies and obtain Investigational Device Exemption (IDE) approvals for the company's clinical projects.

Marie has worked with image-guided minimally invasive surgical systems; active implantable devices for epilepsy; noninvasive vagal nerve stimulators; cardiac and respiratory diagnostic and monitoring devices; peripheral vascular implants; shock wave systems for lithotripsy and sports medicine indications; orthopedic joint, cartilage and ligament implants; bone graft and orthobiologic products; vertebroplasty and disc replacement devices; ENT implants; electrophysiology systems, transcranial magnetic stimulation and neuromodulation devices; and cardiac ablation devices.

Prior to founding M Squared Associates, Marie worked for industry leaders including Howmedica division of Pfizer, Inc. (now Stryker Orthopaedics) and CR Bard Electrophysiology, and was a member of the startup management teams at Intra-Sonix, Cambridge Heart, and HealthTronics. Her prior consulting experience was with Biometric Research Institute (BRI), which was acquired by Quintiles, Inc. She began her career as an RN, working in the operating rooms and emergency departments at LA County / USC Medical Center, UCLA Medical Center, and UCSF Mount Zion Medical Center.

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Marcos Velez-Duran | President, Senior Project Manager II

Marcos joined M Squared Associates in 2006 and is President of the company. He has extensive management experience in the areas of global regulatory requirements for implantable devices; submission and approval of Pre-Market Applications; US regulatory compliance, specifically complaint handling and MDR reporting; and clinical affairs, including the submission and management of IDE and outcomes studies.

Marcos has led the development and deployment of strategy for numerous 510(k) clearances, as well as Pre-IDE, HDE, IDE, and PMA/PMA Supplement approvals, and for a reclassification petition. Marcos has particular expertise in regulatory strategy for combination products, especially enhanced bone grafting materials; injectable hyaluronic acid products; joint replacement devices; spinal fixation and external fixation systems; high intensity ultrasound ablation systems; ultrasonic and electrical bone healing systems; wound healing products; peripheral vascular implants and devices; oncology screening devices; and wireless cardiac monitoring devices. Marcos also serves as the US Representative of foreign clients and has conducted presentations for FDA, company executives, and potential investors.

Before coming to M Squared, Marcos worked for over 18 years in the orthopedic products industry, providing expertise in knee, hip, and trauma devices. He held positions of increasing responsibility at Smith & Nephew Inc. Orthopaedic Global Business Unit, ultimately serving as Vice-President of Regulatory/Clinical Affairs and Quality for Trauma and Clinical Therapies. Prior to Smith & Nephew, he was Manager, Biostatistics and Clinical Computer Operations for Zimmer, Inc. Early in his professional career, he was a research associate in the Department of Pathology, LSU Medical Center New Orleans.

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Janet Johnson Akil | Senior Project Manager I

Janet has over 25 years of experience in the medical device industry working with both small and large firms. Prior to working for M Squared, Janet was Director of Regulatory and Clinical Affairs for Smith & Nephew Orthopaedics. Over the years, she has worked extensively with orthopaedic devices and with other types of medical devices and novel therapies. Janet's leadership, strong writing skills, expertise in regulatory strategy development, and execution of submission strategies have supported numerous 510(k), IDE, PMA and HDE submissions. In addition to US regulatory experience, she is also proficient in International submissions (e.g., European, Australian and Canadian). Her engineering background provides a unique perspective when developing preclinical test strategies used to support regulatory submissions and postmarket evaluations. As Senior Project Manager, Janet is involved in all aspects of regulatory & clinical strategies and works directly with FDA, Notified Bodies, Competent Authorities, and International Regulatory Bodies in coordination of correspondence and meeting preparations.

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Jessica Becker | Quality Project Manager

Jessica joined M Squared Associates in 2018 with over 20 years' experience in the medical device industry ranging from Product Development, Quality Assurance, Quality Control, Manufacturing Operations, Business Development, and Program Management. With a broad understanding of Product Life Cycle Management and deep knowledge in Quality Management Systems, Jessica can provide tactical support as well as strategic direction to accomplish compliance and business goals.

During her career, Jessica has managed units responsible for quality engineering, manufacturing engineering, prototyping, product inspection, metrology, supplier management, internal audits, training, document control, process validation, and distribution quality. Jessica is well-versed in audit/inspection readiness activities and methodology, audit/inspection performance, and interfacing with Regulatory Agencies and Notified Bodies. She has managed several types of projects ranging from re-engineering key processes to various remediation efforts, investigations, and corrective actions.

Prior to joining M Squared Associates, Jessica spent her entire career at Smith & Nephew where she held various management positions responsible for Manufacturing Operations, Quality Assurance, and Quality Control, culminating with her role as the Senior Quality Director responsible for compliance and product quality across all facilities in Memphis.

Jessica holds a Master of Business Administration, with a specialization in Finance, and a Bachelor of Science in Mechanical Engineering, both from Christian Brothers University, Memphis, TN.

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Jennifer Daudelin | Regulatory Project Manager

Jennifer's experience in the medical device industry spans 20 years. She is skilled in the regulatory environment for hip, knee and spinal implants, as well as bone cement and bone substitutes and orthobiologics. In addition to regulatory work for orthopedic devices, Jennifer's expertise includes diagnostic cardiology devices, peripheral vascular devices, donor organ transport systems, and craniomaxillofacial, ENT, and dental devices. She has authored numerous 510(k)s, PMA Supplements and annual reports, Clinical Experience Reports (CERs), EU Design Dossiers and Technical Files, along with many international submissions.

Jennifer began her career in the field of Quality Assurance with a focus on medical device reporting. As a Product Surveillance Supervisor at Howmedica, a Pfizer Company, she played a key role in creating, developing and managing an international product experience database. Jennifer was also responsible for daily operations dealing with FDA's medical device reporting regulations and the European Union's Medical Device Vigilance Reporting. Jennifer then worked at Stryker, where she became a member of the Regulatory Affairs Department. Jennifer was part of the regulatory team that received the first FDA 510(k) clearance for Antibiotic Bone Cement.

Jennifer completed her Master of Science in Jurisprudence (M.S.J.) through Seton Hall University School of Law with a concentration in Pharmaceutical and Medical Device Law and Compliance.

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Dede Flint | CFO

Dede Flint joined M Squared Associates in 2011 following 15 years of experience as a co-owner of TFPS Inc. TFPS provides services including Case Report Form design and printing, database construction, data entry and reporting, and other clinical trial support services. Prior to TFPS, she worked as a Clinical Research Associate and Database Manager for HealthTronics Surgical Services providing team support to achieve PMA approval. Early in her career, Dede served as an Executive Assistant to Armand Hammer, Founder, Chairman and CEO of Occidental Petroleum, and as Executive Assistant to Leo Majich, Chairman of the Board and Fund Manager of the Operating Engineers Trust Fund. Dede has also managed billing and accounting for small law firms.

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Cera Gomez | Project Coordinator

Cera joined M Squared Associates in 2019 as a Project Coordinator. Prior to M Squared she worked as the Quality Assurance and Regulatory Affairs Coordinator at electroCore, Inc. where she helped restructure and sustain their Quality Management System. She is participating in an MDD and MDR gap assessment plan; and supports the clinical research team.

Cera holds a Bachelor of Arts in Communication with a focus in Organizational Communication from Florida International University, Miami, FL.

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Cherita James | Regulatory Consultant III

Cherita joined M Squared Associates in 2004 and has since authored multiple successfully cleared 510(k) applications, co-authored numerous PMAs and PMA supplements, and participated on the project team for a Humanitarian Device Exemption (HDE). She has particular interest and expertise in preclinical testing requirements and protocols, software verification and validation requirements, and FDA Quality System Regulations, especially Design Controls.

Cherita works with many clients based outside of the United States to design and implement complementary Quality Systems and ISO 13485 programs, assist in registration and listing requirements, and serve as Official US Representative. She prepares clients for FDA Quality Systems inspections and serves as an on-site representative o0r advisor during inspections. Her experience includes perinatal monitoring devices; wireless monitoring devices; adult apnea devices; cranioplasty devices and instruments; mammography and other oncology screening devices; dental diagnostic devices and implants; muscle and nerve stimulation devices; bone growth devices; endoscopic devices; ENT implants and instruments; and tumor ablation devices and guiding systems.

Prior to joining M Squared Associates, Cherita managed applications and training for HealthTronics Surgical Services and was a senior clinical specialist for High Medical Technologies USA, both shock wave device companies. She is a Radiology Technician certified in Nuclear Medicine Technology and in Basic Magnetic Resonance Imaging, and spent 15 years working in hospital and mobile settings. She has completed training and was certified as an Auditor / Lead Auditor for ISO 13485.

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Deborah Lavoie Grayeski | Senior Project Manager I

Deborah has 15 years of experience in regulatory and clinical affairs for the biologics and medical device industry. Her areas of therapeutic expertise include peripheral vascular, cardiovascular, ENT, embolization devices, dental and orthopedic devices, with particular technological expertise in cell, tissue and gene therapy products, implantable devices, minimally invasive surgical systems, and imaging devices. Deborah works effectively with both large corporations and small start-up companies.

As Senior Project Manager, Deborah is involved in all aspects of regulatory & clinical strategies and works directly with FDA in coordination of correspondence, negotiations, meeting preparations, regulatory submissions and post-market activities. Deborah's primary activities include regulatory strategy development for Class I, II & III devices and biologics, and preparation of 510(k), PMA, HDE, IDE, IND, BLA, and international regulatory submissions, including regulatory submissions for device/biologic and device/drug combination products.

Formerly with G.E. Healthcare, Deborah held the position of Director, Regulatory Affairs Programs, followed by Global Manager, RA. Prior to her work with G.E., she served seven years with FDA, elevating to Supervisory Consumer Safety Officer, (Branch Chief, Regulatory Project Management), at FDA's Center for Biologics Evaluation and Research, Office of Cellular Tissues and Gene Therapies (now known as the Office of Tissues and Advanced Therapies (OTAT)).

Deborah holds a Juris Doctor and is RAC certified.

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Joyce Ludwig | Quality Consultant III

Joyce joined M Squared Associates in 2013 and has since developed regulatory strategies and created Quality Management Systems for compliance to FDA, ISO13485/MDD/MDR regulations, and MDSAP requirements specifically tailored to individual start-up companies. She has particular interest and expertise in Risk Management, Design Controls and CAPA.

Joyce works with many clients who are established as virtual companies in the US and provides assistance to OUS medical device companies entering into the US. She prepares clients for FDA, ISO 13485/MDD/MDR and MDSAP Quality Systems inspections, Technical File assessments and serves on-site during inspections. Joyce assists clients with remediation from regulatory inspections. Her experience includes orthopedic joint and spine implants and instrumentation; tissue adhesives; active non-implantable devices; bioresorbables; injectable hyaluronic acid; dental implants; trauma implants, tissue banking, sterilization systems; and guiding systems.

Prior to joining M Squared Associates, Joyce managed Quality Systems, Regulatory and Clinical Departments at three global and several small start-up medical device companies.

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Gary Lynch | Quality Consultant III

Gary has over 30 years' experience in the medical device industry in R&D, Manufacturing Operations, and Quality/Regulatory. He has developed and improved Quality Management Systems in large medical device OEMs and small start-ups. Gary can provide strategic direction in developing a QMS or can tactically deliver detailed standard operating procedures.

Gary has performed numerous due diligence exercises for potential acquisitions in the medical device industry. He has led 483 and warning letter remediation efforts including quality plan development and has hosted follow-up audits. Gary can provide FDA readiness including front room/back room training in preparation for FDA or ISO audits.

During his career Gary has managed units responsible for quality engineering, statistical process control, product inspection, supplier management, design control, complaint handling, post market surveillance, field action execution, internal audits, document control, training, process validation, microbiology, calibration, and product ID/traceability.

Prior to joining M Squared Associates in 2015, Gary spent his entire career at Smith & Nephew where he held various management positions responsible for Quality in the US and globally.

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Ian MacPherson | Database Coordinator

Ian joined M Squared Associates full time in 2015 after working as an independent contractor during the previous year. Prior to M Squared he worked at Travelers Insurance in the Business Analytics department specializing in database management and creating new analysis methodologies. As a Database Coordinator, Ian manages the data for clinical trials including data entry, data validation, and analytics. He also assists team members on various projects and works with them to submit PMAs, 510(k)s and other materials to the FDA. He also manages M Squared's Electronic Submissions Gateway (ESG) with the FDA.

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Anne McKibbin | Clinical Project Manager

Anne joined M Squared Associates in 2018. Before joining M Squared, Anne worked as the South Carolina Statewide Forensic Nurse Examiner Coordinator, providing leadership by collaborating with government and non-government partnering agencies to develop and implement policies and procedures based on best clinical practices, federal and state regulations, and local infrastructure. She procured and maintained grant funding, audited sub-grantee sites for compliance with grant terms and regulations, conducted clinical research, published in peer-reviewed journals, and presented scholarly work at conferences. She recently served in a similar capacity for the County of Tuscaloosa AL, where she was the Coordinator for the Domestic Violence Task Force. Anne has also been an instructor at the University of Alabama Capstone College of Nursing, where in addition to developing and implementing coursework she conducted clinical research, published in peer-reviewed journals, and presented her work at conferences.

Earlier in her career, Anne was a Clinical Research Associate at HealthTronics, Inc, providing investigational site management and study monitoring for Class III medical device trials. She assisted in the development, content and preparation of clinical protocols, informed consents, case report forms, and study related documents/tools, including monitoring plans, site visit reports and all study site correspondence. Anne was also an Orthopaedic Sales Representative for Wright Medical. She began her professional career as an intra-operative/post-operative nurse and orthopaedic team manager at Baptist Hospital, Nashville TN.

Anne holds a Doctorate in Nursing Science, a Master of Science in Nursing, and a Certificate in Forensic Science and Law from Duquesne University. Her Bachelor of Science in Nursing is from Western Carolina University.

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Katie Miller | Senior Biostatistician

Katie has over 10 years of experience in the medical device industry. Her expertise is in the area of biostatistics, where she has provided support for regulated and post-market studies worldwide, including protocol development, study design, sample size calculations, annual reports, and clinical study reports to support FDA submissions and product registrations. Katie also prepared and reviewed statistical analyses to support publications and white papers, field communications, and outcomes research.

Katie began her career as a SAS programmer and Biostatistician at Zimmer, Inc., where she programmed tables, listings, and analyses to support hip, knee, spine, and biologics studies. She then worked at Biomet, Inc. as a Biostatistician and manager of the Clinical Evidence team, which included statisticians, medical writers, and database coordinator. Katie then worked at Zimmer Biomet as a biostatistician, supporting worldwide regulated and non-regulated studies.

Katie has a degree in mathematics from Taylor University and a Master of Science in Statistics (M.S.) from Miami University.

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Jonathan Mulligan | Senior Clinical Research Associate

Jonathan joined M Squared Associates in 2013 as a Clinical Research Associate, adding his experience to the firm's clinical expertise. He has served many roles in the management of several large, multi-center clinical research studies both in and outside of the United States. These roles include Clinical Study Manager, Site Manager, and Clinical Monitor. His responsibilities in these roles include preparing IRB/EC submissions, site coordinator training, Site Initiation Visits, Case Report Form creation, protocol development, authoring clinical study reports and Adverse Event narratives.

Jonathan is also experienced in conducting mock FDA Bioresearch Monitoring (BIMO) audits for study sites, sponsors, and CROs in the U.S. and in Europe. He has developed a comprehensive audit readiness program to prepare all staff for likely interview questions and overall audit conduct as well as identifying likely findings and implementing preemptive corrective action.

Jonathan has been an active member of the Association of Clinical Research Professionals (ACRP) for many years. His experience prior to joining M Squared Associates includes Senior Project Manager for an Independent Medical Exam company and independent monitoring of various types of clinical trials.

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Niha Patel | Clinical Research Associate I

Niha joined M Squared Associates in 2017 as a Clinical Research Associate. Niha manages IRB submissions and site communication, creates case report forms, identifies investigational sites, provides site coordinator and study team training and conducts site qualification, site initiation, and interim monitoring visits for medical device trials. She also provides support for clinical projects including protocol review and development, study recruitment tool design (e.g. flyers, brochures, print/digital advertisements), and study trial master file management.

Niha's experience prior to M Squared Associates includes working with children and vulnerable populations by serving as a clinical research coordinator on multiple studies at Gillette Children's Specialty Healthcare and Children's National Medical Center in their pediatric orthopaedics departments, as well as, a research assistant for various therapeutic areas. In these roles, she has had first-hand experience in multicenter research projects, protocol development, IRB submissions, subject screening and recruitment, data collection and database design, data analysis, manuscript preparation, and study billing and invoicing.

Niha completed her Master of Public Health (MPH) in August 2017 through University of Minnesota - Twin Cities with a concentration in Environmental & Occupational Epidemiology. She also is a Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals (ACRP).

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Connie Qiu | Regulatory Consultant III

Connie joined M Squared Associates in 2018. Her experience encompasses regulatory submissions for various types of medical devices including software, ultrasound, dural sealants, and neurosurgical equipment. Connie has prepared regulatory strategies, 510(k)s, PMA Supplements and Annual Reports, EU Technical Files and Change Notifications, and other international submissions. She also implemented and maintained quality management system for a startup, hosted FDA and Notified Body audits and successfully led remediation efforts. Connie enjoys working with large and small companies, and different medical technologies.

Connie began her career as Clinical Research Associate at the Cardiovascular Research Foundation, analyzing data to support coronary stent studies. She then joined Integra LifeSciences as a Quality, Regulatory, and Clinical Associate and was promoted to Sr. Regulatory Affairs Specialist during her tenure. At Integra, Connie prepared a range of submissions for the US, European Union, and Asia Pacific. Just prior to M Squared, Connie was Quality and Regulatory Affairs Analyst at UltraLinq Healthcare Solutions, where she managed US and EU regulatory files, implemented and maintained a quality management system for software medical devices. Connie holds a Master of Engineering degree in Biomedical Engineering from Cornell University and maintains current RAC certification.

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Marcia Salmon-McKay | Office Manager

Marcia has over 28 years of administrative experience, and has been with M Squared since 2014, providing valued administrative support for our finance, regulatory affairs, and clinical research teams. Marcia is experienced in preparing regulatory submissions and ensuring compliance with FDA's eCopy requirements, and also handles any client billing inquiries.

Prior to joining the M Squared family, Marcia worked at MicroBridge Software Associates in Jamaica for 14 years as Office Manager, before immigrating to the USA in 2011 and becoming a citizen in 2016. Marcia's motto: Teamwork makes the dream work!

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Beatriz Vendrell-Velez | Clinical Research Associate I

Bea joined M Squared Associates full time in 2017 as a Clinical Research Assistant after working with us as an Intern. Bea provides support for clinical projects, managing investigator meetings, site communications, and study newsletters, and establishing and maintaining study trial master files (TMF, eTMF). As a Clinical Monitor, she manages IRB submissions, case report form creation, and site coordinator and study team training, and conducts site qualification visits, site initiation visits, and investigational site monitoring for medical device trials.

Bea's experience prior to joining M Squared Associates includes conducting multiple research projects as a Graduate Assistant under the mentorship of Dr. Jennifer Horney, Dean of the Epidemiology and Biostatistics Department of the Texas A&M Health Science Center.

Bea completed her Masters of Public Health (MPH) in May 2017 through Texas A&M Health Science Center with a concentration in Epidemiology and Biostatistics.

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Peter Weiman | Director of Clinical Programs

Pete has more than 17 years of global experience within the device industry, having conducted/managed studies in the USA, EU, South Africa, Canada, Mexico, and Australia. He has experience working on the Sponsor side as well as experience working with small and large CRO companies. Pete's ability to maintain focus on the global goals of the clinical program while managing the details is vital for successful clinical trial execution, and he has successfully managed Significant Risk and Non-Significant Risk IDE studies for Class III (PMA) and Class II (510(k)) devices from early development of the protocol to post study requirements including audits and post market surveillance.

As the Director of Clinical Programs at M Squared, Pete is responsible for direct client communication, development and maintenance of project budgets, ensuring adequate resourcing, and meeting individual project goals, objectives, and timelines. Pete also manages studies and audits for outside US studies to support FDA submissions, and can help clients find cost-effective alternatives by building partnerships with foreign CROs.

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Diann White | Senior Project Manager I

Diann has over 25 years of experience with orthopedic, dental and urologic medical devices working with a variety of products including bone grafting materials, injectable hyaluronic acid products, joint replacement devices, spinal fixation systems, high intensity ultrasound ablation systems, ultrasonic bone healing systems and catheters.

As Senior Project Manager, she relies on her extensive experience in preparation and approval of PMA and IDE applications, writing Clinical Study Reports, Annual Progress Reports, deficiency letter responses and audit responses, and face-to-face interactions and negotiations with FDA including Day 100 meetings and BIMO audits. Additionally, she has designed and managed IDE, marketing and international studies, and prepared Continued Access applications, Compassionate Use applications and Emergency Use reports.

Prior to working for M Squared, Diann was Director of Clinical and Regulatory Affairs at Wright Medical Technology, Inc., Director of Clinical Research for Smith & Nephew Biologics and Spine, and Director of Clinical Research at Campbell Foundation.

Diann is a Certified Clinical Research Professional.

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