Brochures

Brijesh Patel

Chief Executive Officer

Brijesh Patel is the co-founder & Chief Executive Officer (CEO) of Enhanced Compliance Inc. Brijesh has more than 25 years regulatory compliance and quality management systems experience in life sciences industries.

His professional journey includes impactful consulting roles, where he has provided expert consultations to a diverse spectrum of clients in the medical device, pharmaceutical, and biotech industries, addressing challenging regulatory compliance concerns. Prior to his consulting career, Brijesh held quality leadership positions at organizations such as Teva Pharmaceuticals and Abbott Laboratories. His contributions to organizational growth extend beyond his core competency in regulatory compliance leadership and into other areas of the business, enabling him to provide a higher level of service for client companies across a broad spectrum of verticals in the life sciences industry. He is known for his strong technical acumen, collaborative leadership, meticulous attention to detail, and unshakable work ethic. In a business environment in which regulations are constantly changing, and quality improvement is an ongoing challenge for organizations, Brijesh supports clients in managing the complexities of regulatory compliance. He brings a structured approach to problem solving and steps up when his clients are at their most vulnerable. A big-picture thinker who facilitates continuous improvement systems and processes, Brijesh is driven by the potential of doing something special and making a lasting positive impact on businesses and lives across global borders.

Brijesh holds a Bachelor of Science degree in Chemistry from Governors State University, Illinois.

In his free time, Brijesh is passionate about sports, particularly cricket. He also loves watching movies and reading.

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Brijesh Patel

Chief Executive Officer

+ Years of Experience

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Shital Patel

Chief Operating Officer

Shital Patel is the co-founder and Chief Operating Officer (COO) of Enhanced Compliance Inc. Her distinguished career includes more than 17 years of consulting experience, and 18 years of project management, engineering, validation, and compliance expertise in the pharmaceutical and medical device industries, spanning both start-ups and Fortune 500 corporations.

Shital has held positions of increasing responsibility in medical companies such as Abbot, where she supported the consent decree, and Densply. Her extensive consulting experience includes clients such as BSC (where she consulted for over 10 years continuously) Atrium (Getinge); Heartware (Medtronic) and Cook Medical. She has led risk reduction efforts within these manufacturing environments by ensuring conformance to established control mechanisms for quality systems excellence in the areas of Validation, CAPA, Risk Management, and Design Control. Shital is a subject matter expert in ISO13485, ISO14971, ISO9001 FDA21CFR Part 820,FDA21CFR Part 11 and other standards (domestic and international) relevant to the medical devices and pharmaceutical sectors.

Shital received her Bachelor of Science Degree in Bioengineering from the University of Illinois.

In her free time Shital loves to spend time with her friends and family. She is an avid foodie and is enthusiastic about experimenting with new recipes and exploring different cuisines.

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Shital Patel

Chief Operating Officer

+ Years of Experience

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Michael Boyer

President/Chief Financial Officer

Michael “Mike” Boyer was appointed to the role of President of Enhanced Compliance Inc, after originally joining the Company as Chief Financial Officer in August 2022. Mike brings over 20 years of executive leadership experience to ECI from a broad range of industries including professional services, consulting, manufacturing, and investment banking.

Prior to ECI, Mike spent 6 years at G2 Capital Advisors as a Managing Director. Over the course of his career, he has optimized value for both publicly traded and privately held organizations, using a servant-leader approach to promote the employee experience and foster the client relationship as a trusted advisor.

Mike holds a Bachelor’s Degree in Accounting from LebanonValley College in Annville, PA, where he also subsequently served as an adjunct professor.

Mike spends his free time volunteering as a boat captain on the Gulf of Mexico during sea turtle nesting season, from May to October.

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Michael Boyer

President/Chief Financial Officer

+ Years of Experience

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Jeff Kisslinger

Vice President of Commercialization

Jeff Kisslinger has over 20 years of diverse experience working in FDA regulated and healthcare industries with a focus on business development and commercial leadership. Jeff currently is serving Enhanced Compliance Inc. (ECI) as the Vice President of Commercialization overseeing both the Business Development and Marketing teams.

Prior to joining ECI, Jeff oversaw market strategy and commercial activities including the development and leading of Business Development teams delivering complex and technical sales for large and mid-size companies. Jeff’s efforts to build and support organizational knowledge, GMP compliance and enhance regulatory engagement have had a significant impact on the organizations he has supported.

Jeff received his Bachelor of Science degree in Biology from Southeast Missouri State University, MBA from Webster University and his Master of Science from Washington University.

Outside of work, Jeff is an amateur astronomer and has been nominated for several awards for his images of the night sky. He also plays tennis, loves to read and travel around the world.

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Jeff Kisslinger

Vice President of Commercialization

+ Years of Experience

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Orla Blount

Senior Director of Business Development

Orla is the Senior Director of Business Development at Enhanced Compliance Inc. She has over 20 years of medical device industry experience in R&D, Quality and Business Development. Prior to her current role, Orla served as ECI’s Director of Program Management Office (PMO).

Before joining ECI in 2016, she held positions of increasing responsibility at Boston Scientific and St Jude Medical. Over her career she has worked with domestic and international requirements on single use, reusable and capital medical devices and equipment. She has extensive knowledge of various specialized areas of medical practice, including peripheral interventions, cardiovascular, oncology, urology and women’s health, endoscopy, and a variety of devices used for diagnostic, preventive, and therapeutic purposes. Additionally, Orla holds nine US patents for medical devices.

Orla received her Bachelor of Science (Hons) degree in Biomedical Engineering from the University of Ulster, Jordanstown, Northern Ireland. She also graduated cum laude from Babson College, Wellsley MA with a Master of Science in Management and an MBA from Babson College, Wellesley, MA.

In her free time Orla enjoys cooking, traveling and long hikes with her family and two dogs.

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Orla Blount

Senior Director of Business Development

+ Years of Experience

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David DeFaria Castro

Director of Business Development (Latin America)

David De Faria is the Business Development Director for Latin America at Enhanced Compliance Inc. David has more than 15 years of professional experience in a multinational commercial environment, for medical devices and advanced manufacturing industry.

Prior to ECI, David held responsible positions in companies such as Mabe, Sylvania, Procomer, Hologic and Expeditors. He has overseen regional and international efforts for near shoring, cost reduction and business continuity programs for life sciences OEM, contract manufacturers and suppliers in different tiers.

David received his Master’s Degree in Medical Devices Engineering and Industrial Design Engineering from the University Technological Institute of Costa Rica.

In his free time David is passionate about helping his community; he helped found the first development association in his town and was elected district counselor in the local town hall. He also loves sharing his knowledge, chatting to people, drinking tea and playing chess.

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David DeFaria Castro

Director of Business Development (Latin America)

+ Years of Experience

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Juan Carlos Rodriguez

Director of Operations (Latin America)

Juan Carlos Rodriguez is the Director of Operations at Enhance Compliance Inc. for the LATAM region. Juan Carlos, a seasoned global leader in engineering and operations, brings over 15 years of experience and a proven track record of success within the medical device industry.

His extensive background includes specialized expertise in new product introduction, marked by the successful launch of products for Boston Scientific and Confluent Medical. Renowned for his disciplined and decisive leadership style, Juan Carlos excels in both medical device design and manufacturing, showcasing a unique blend of high business and technical acumen. From R&D to manufacturing and commercialization, Juan Carlos consistently meets timeline and budget commitments, prioritizing high-quality standards and patient safety. Additionally, he has demonstrated a proven ability to collaborate with cross-functional leaders on strategic planning and procedural design, driving continuous organizational improvements. In his previous roles, Juan Carlos led teams to success, contributing significantly to the overall organizational achievements. With experience as Head of Engineering, R&D Engineering Manager, and Principal R&D Engineer, he showcased expertise in team management, innovation, and successfully launching medical devices, playing a pivotal role in driving revenue growth and operational excellence.

He received a bachelor's degree in mechanical engineering from the University of Costa Rica and a Master's in Business Administration from the Kelley School of Business at Indiana University.

Juan Carlos loves to spend his free time with his family, on the beach and hiking in the mountains. He also loves boxing and mountain biking.

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Juan Carlos Rodriguez

Director of Operations (Latin America)

+ Years of Experience

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Hiral Patel

Director of Information Technology

Hiral Patel is the Global Director of Information Technology at Enhanced Compliance Inc. Hiralis an enthusiastic and innovative professional with over 22 years experience in IT.

She has spear-headed IT initiatives that have resulted in the delivery of exceptional solutions and expertise across key areas, including Microsoft Azure, Cyber Security, Microsoft 365 and Deltek Vantagepoint. Prior to ECI, Hiral spent 12 years in Amec Foster Wheeler, Hitachi, AT&Tand ADP. Her technological expertise & background in system design has led to the success of numerous IT infrastructures; the construction of a comprehensive IT solution from scratch and in ensuring global security for the organization.

She holds a Bachelor’s degree in Information Technology from Franklin University.

Hiral dedicates her free time to raising educational funds for underprivileged girls. She is also an avid yoga practitioner.

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Hiral Patel

Director of Information Technology

+ Years of Experience

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Amy McCormack

Director of Human Resources

Amy McCormack is the Global Director of Human Resources for ECI. Amy oversees all human capital initiatives including resource management, recruiting, total rewards, employee engagement, and workforce compliance. She has over 20 years of experience in developing, implementing, and improving human capital processes and initiatives resulting in organizational improvements.

Prior to joining ECI, Amy oversaw all HR operations at Audax Group and its affiliate companies globally. She also worked at G2 Capital Advisors and Beyond Finance leading their human capital teams focusing on developing and implementing best-in-class people strategies. Amy started her career in the talent management field working within the learning and development space at both PwCand Bain Capital.

Amy holds a Bachelor of Science degree in Mass Communications from the University of Hartford in Connecticut.

In her freetime, Amy is an avid skier and cyclist, participating annually in the 2-day Pan-Mass Challenge ride.

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Amy McCormack

Director of Human Resources

+ Years of Experience

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Maylin Truesdell

Director of Regulatory Affairs

Maylin “May”, Truesdell, serves as the Director of Regulatory Affairs at Enhanced Compliance Inc. With a distinguished career spanning over 15 years, she is a seasoned global Regulatory Affairs leader with expertise in both US and international regulatory landscapes.

May specializes in diverse medical devices, including digital health, in vitro diagnostics (IVD), cardiovascular, endoscopy/urology, and combination devices. Her professional journey includes impactful Regulatory Affairs roles at companies such as Boston Scientific, Medtronic/Covidien, and various innovative startups in the Boston area. She has led teams of Regulatory Affairs professionals, focusing on new product development projects, EU MDR Submissions, and post-market/sustaining-engineering projects.

May received her Bachelor’s Degree in Biology, and Master’s Degree in Health Product Regulations and Health Policy from Regis College in Weston, MA.

In her free time, May enjoys spending time with her family, hiking, skiing and snowboarding.

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Maylin Truesdell

Director of Regulatory Affairs

+ Years of Experience

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Karen Heffernan

Director of Quality & Compliance

Karen Heffernan serves as the Director of Quality & Compliance at Enhanced Compliance Inc. Karen has over 40 years extensive experience in the medical device industry and a significant functional background in Operations, Regulatory, Quality and the on-boarding of New Product Development programs.

Prior to joining ECI, Karen served as Director of Quality at Abiomed and Director of Quality at Boston Scientific. She has led teams in Manufacturing, Pilot Manufacturing, Quality, Regulatory, Compliance, Quality Systems, Post Market Surveillance, and Remediation activities. She also held senior positions in medical companies such as C.R. Bard and Medtronic. Karen has extensive experience in Process Improvements, Compliance, Quality Systems, and Remediation activities. Additionally, she is proficient in the areas of FDA21CFR Part 820, ISO13485, ISO14971and ISO149001.

Karen attended Franklin Pierce College and Southern New Hampshire University.

In her free time, Karen loves to travel and ride motorcycles in the countryside.

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Karen Heffernan

Director of Quality & Compliance

+ Years of Experience

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Sean T. McCarthy

Senior Regulatory Manager

Sean T. McCarthy serves as the Senior Regulatory Manager at Enhanced Compliance Inc. With over 20 years of experience, he is a seasoned regulatory affairs leader with a strong background in medical devices, diagnostics, and healthcare compliance.

Sean has worked extensively with the FDA and global authorities, guiding regulatory strategy, submissions, and quality system certifications across innovative technologies such as wearables, IVDs, and therapeutic devices. Prior to joining ECI, he held senior regulatory roles at YourBio Health, Philips Medical Systems, and Mevion Medical Systems.

He holds a J.D. from the University of Massachusetts School of Law and a B.A. in English from the University of Maine. Admitted to practice law in Massachusetts since 1994, Sean enjoys coastal living.

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Sean T. McCarthy

Senior Regulatory Manager

+ Years of Experience

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Discover Our Specialized Solutions

Brochures that showcase our expertise in compliance, quality, and innovation

Brochures

Brijesh Patel

Chief Executive Officer

Shital Patel

Chief Operating Officer

Michael Boyer

President/Chief Financial Officer

Jeff Kisslinger

Vice President of Commercialization

Orla Blount

Senior Director of Business Development

David DeFaria Castro

Director of Business Development (Latin America)

Juan Carlos Rodriguez

Director of Operations (Latin America)

Hiral Patel

Director of Information Technology

Amy McCormack

Director of Human Resources

Maylin Truesdell

Director of Regulatory Affairs

Karen Heffernan

Director of Quality & Compliance

Sean T. McCarthy

Senior Regulatory Manager

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