Regulatory and Clinical Services specializing in the Medical Device Industry

Meet the People of M Squared

Marie Burgett

Senior Clinical Project Manager

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Marie’s extensive experience in cardiovascular critical care is the result of 10 years as clinical nurse at Washington Hospital’s Electrophysiology Lab before focusing on clinical research. Since joining M Squared, she has managed clinical study projects in the areas of Oncology and Diabetes, working directly with study sponsors and clinical monitors.  Marie engages the entire study team including the sponsor, participating sites and colleagues.  Emerging companies, new to the daunting task of executing a clinical study, benefit from Marie’s experience and communication skills by receiving careful guidance through out the process.

 

Cherita James

Regulatory Consultant II

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Cherita has authored several successfully cleared 510(k) applications and co-authored numerous PMA/PMA supplement approvals.  Cherita’s background in nuclear medicine & x-ray technology has evolved to encompass cutting edge technology such as Bluetooth, wireless and software driven device products, all of which she has helped bring to market since joining M Squared.  She determines testing requirements and ensures compliance and adequacy of documentation regarding non clinical safety and effectiveness, e.g. pre clinical studies, analytical methods and GLP’s. Cherita’s experience provides the ability to offer assistance with US FDA GMP and Quality System Regulation, and ISO 13485 consulting services.  Cherita acts as the Official US Representative for a number of M Squared’s clients and assists in registration and listing requirements.

Marie Marlow

Founder & CEO

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Marie founded M Squared Associates in 2001 based on her desire to create an environment for bright, talented, highly motivated, self-directed people to work together towards professional and personal excellence.  Throughout over 20 years in the medical device industry, Marie has approached the FDA regulatory process as an opportunity to develop creative and strategic approaches to bringing new products and technologies to market.  Her early career as an R.N. gave her an appreciation for how well-designed, well-manufactured medical products improve and save lives, and how innovative ideas can translate into these benefits.  Marie has held regulatory and clinical management positions with large corporations including “Pfizer” and “C. R. Bard,” as well as for several early stage medical device companies.  The diversity in the size and types of device companies for which she’s worked has fostered her philosophy that each project has unique characteristics and challenges, and that it is the responsibility of the M Squared team to fully understand the nature of those characteristics and challenges in developing and executing a regulatory strategy.   Her more recent experience includes management of several successful Premarket Approval Applications (PMA), strategic planning and presentation of the PMA’s before FDA Medical Device Panels, development of regulatory strategy plans for both large and small medical device firms, and successful appeals of FDA regulatory determinations. Her clinical areas of expertise include orthopaedic, general surgery, and cardiovascular devices.

Terry Sheridan Powell

Senior Project Manager I

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Terry spent 15 years in the Orthopaedic industry, first as Team Leader for Regulatory Affairs and Clinical Research with “Stryker Orthopaedics” then as an independent regulatory affairs consultant.  Terry has extensive experience working with Orthopaedic, spinal and bone substitute devices and expertise in 510(k), PMA and IDE strategy development and execution.  She is part of a team that assists clients in developing engineering rationales and interpreting them as part of submission. Her leadership and strong writing skills have supported numerous successfully cleared 510(k) applications and PMA/PMA Supplement approvals.  Terry works directly with FDA as the main contact for client correspondence and official meetings.

Marcos Velez-Duran

President

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Marcos worked side by side with leaders in Orthopaedic products including “Smith & Nephew” and “Zimmer” over 18 years in the medical device industry.  His expertise includes knee, hip, and trauma devices and he has developed the strategy for combination, high intensity ultrasound, wound healing & ablation devices. Working with both start up companies and multi-national corporations, Marcos has lead the development & deployment of strategy for numerous 510(k) clearances and Pre-IDE, HDE, IDE, PMA/PMA Supplement approvals.  Marcos serves as the US Representative of foreign clients conducting presentations for FDA, company executives, and potential investors

Pete Weiman

Senior Clinical Project Manager

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Pete is an occupational therapist with more than 10 years of experience within the device industry, specializing in Orthopaedics, lithotripsy and electrical stimulation. Pete’s communication skills, motivating personality and ability to maintain focus on the global goals of the clinical program while managing the details are all vital elements in a successfully executed clinical trial and he has successfully managed Class III (IDE-PMA), 510(k) and Non-Significant Risk studies from early development of the protocol to post study requirements including audits and post market surveillance. As FDA’s clinical sponsor contact, Pete aides in organizing pre-IDE meetings, prepares adverse event reports and annual & study close out reports. 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  CRO’s.

Deborah Lavoie Grayeski, J.D., RAC

Senior Project Manager l

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Formerly with GE Healthcare, Deborah held the position of Director, Regulatory Affairs Programs, followed by Global Manager, RA.  Prior to her work with GE, 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.  As Senior Project Manager, Deborah is involved in all aspects of regulatory & clinical strategies and works directly with FDA in coordination of correspondence and meeting preparations.

 

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