With a background in AI, algorithms, and biomedical engineering, she excels at building and leading high-performing, tech-driven companies. As CEO of Pure Global, she has pushed for global growth across 15+ markets, enabling MedTech clients to access 30+ countries with a cutting-edge, AI-driven approach.  Prior to Pure Global, Phyllis held mission-critical roles at Google as a technical team leader and at Citadel Securities as a quant researcher. In these positions, she consistently delivered innovative solutions, leveraging her deep understanding of AI and algorithms within data-driven environments. With a foundation forged in the dynamic environments of Silicon Valley and Wall Street, she brings a unique perspective to leadership.  She builds world-class teams defined by integrity, excellence, and high efficiency, always pushing the boundaries of what's possible with AI and technology.  As a results-oriented leader with a keen eye for market opportunities, Phyllis is passionate about using technology and data insights to drive rapid growth for Pure Global and its customers.  Phyllis holds a master's degree in computer science from Carnegie Mellon University and a bachelor's degree in biomedical engineering from Shanghai Jiao Tong University.

His engagements have included leading initiatives for Fortune 500 companies and government agencies, showcasing his ability to navigate complex organizational landscapes and deliver impactful solutions. He possesses a unique blend of business acumen and deep technical expertise, enabling him to identify market opportunities, build high-performing teams, and deliver cutting-edge solutions that generate significant value. As a serial entrepreneur, DJ has a proven track record of success in building and scaling businesses from the ground up. He excels at all stages of company creation, from ideation and product development to go-to-market strategy and operational execution. His ventures have consistently achieved rapid growth and profitability, fueled by his strategic vision and ability to assemble and motivate talented teams. DJ's technology leadership spans across finance, energy, and healthcare sectors. He has consistently delivered impactful results in areas such as AI/ML, cybersecurity, software engineering, and cloud infrastructure. His expertise lies in driving digital transformation initiatives that optimize operations, enhance security, and unlock new possibilities for businesses. He holds a Master of Science in Information Security from Carnegie Mellon University and dual Bachelor of Science degrees in Finance and IST from Pennsylvania State University.

He specializes in regulatory compliance, international submissions, and quality management systems, combined with expertise in cross-functional team coordination across international markets. He navigates complex FDA and ISO standards, with a proven track record of managing global regulatory activities to ensure product compliance and market access. Wong excels at building effective working relationships with regulatory agencies and driving projects that align with organizational goals and regulatory standards. Prior to joining Pure Global, Wong was a web developer at Hawkeye. He holds a Bachelor of Science in Computer & Electrical Engineering from New York Institute of Technology.

He specializes in diagnostics and provides strategic guidance on global regulatory compliance, FDA submissions, clinical studies, and international product registrations. With more than 100 FDA PMA and 510(k) approvals, Robert has helped manufacturers of all sizes navigate complex regulatory challenges, including clinical study design, software validation, and design control process development. His expertise also extends to healthcare public policy and compliance across various international markets.

Prior to joining Pure Global, Di Tullio held vice president positions at Alere and Siemens Healthcare. He holds a bachelor’s degree in biology and chemistry from Saint Joseph’s University in Philadelphia.

She specializes in large-scale medical device and IVD regulatory strategy, product registrations, post-registration processes, and product lifecycle management. She also coordinates strategic communication with regulatory agencies, particularly ANVISA in Brazil. Her background as a pharmacist facilitates her strategic and regulatory insight to registration projects for medicine products.Prior to joining Pure Global, Monteiro held regulatory affairs positions at IQVIA, Blau Farmacêutica, and Bayer. She holds a bachelor’s degree in pharmacy from Universidade São Judas Tadeu and a postgraduate degree in clinical pharmacology from the Hospital Research Institute in Brazil.

She specializes in medical device and cosmetics registration of all risk classes with ANVISA in Brazil, as well as Brazil GMP certification and Brazilian certifications (INMETRO, ANATEL). In her role at Pure Global, she works on Brazil (ANVISA) medical device registration projects. She is a certified lead and internal auditor in ISO standards, including ISO 9001: 2015, ISO 19011: 2018, ISO 13485: 2016 and RDC 665/2022.Prior to joining Pure Global, de Miranda held regulatory consulting positions at renowned companies in Brazil. She holds a bachelor’s degree in chemical engineering from Universidade Estadual de Maringá in Brazil.

Her areas of expertise include enhancing organizational efficiency through effective financial oversight, strategic HR administration, and seamless project management. Oliveira’s proactive approach to problem-solving and engaging with stakeholders fosters innovation in evolving business models. Her legal background supports her management of legal and regulatory documentation for company operations.Prior to joining Pure Global, Oliveira held operations and regulatory affairs positions at Emergo by UL Solutions. She holds a Bbachelor‘s degree in law from the Faculty of Social and Technological Sciences in Brazil.

Marcelo Brisolla is an experienced attorney and regulatory expert who specializes in sanitary legislation and medical device regulation. In his 30-year career, he has guided multinational companies through Brazil’s medical device regulatory landscape, particularly with ANVISA. As founder and CEO of Brisa Advisors and Brazil Import Healthcare Solutions, with expertise M&A, compliance, and global regulatory strategy, he has successfully introduced innovative healthcare products to the Brazilian market.Prior to joining Pure Global, Brisolla was Chief Operations Officer at 3A Mate and Managing Director at Emergo Brazil. He holds a Bachelor‘s degree in law from the Centro Universitario do Distrito Federal and a Master’s degree in marketing from The Higher School of Advertising and Marketing in Brazil – ESPM.

She has secured over 700 health registrations and managed numerous trademark prosecutions, showcasing her expertise in complex regulatory environments. She is skilled in strategic negotiations, especially in counterfeiting cases. Sandra is dedicated to protecting clients' interests and remains at the forefront of regulatory developments through her active participation in industrial property seminars.García is a partner at SVip Abogados. Prior to joining Pure Global, she was head of trademarks at Clarke, Modet & Co. She holds a law degree from Universidad Externado de Colombia.

He specializes in medical device and IVD regulatory submissions for Mexico market entry, health compliance, and bioequivalence studies and clinical studies. For eight years, he was a Chemical Evaluator at COFEPRIS, Mexico’s medical device regulator. Axel Juarez has facilitated COFEPRIS approvals related to Market Registrations and Technovigilance, as well as the implementation of QMS for medical devices in cardiology, endodontics, respiratory therapy, urology and more.

Prior to joining Pure Global, Axel Juarez held regulatory consulting positions at Laboratories Jayor, DVA Mexicana and Belenus Pharm in Mexico city. He holds a degree in chemical engineering from The National Autonomous University of Mexico.

She is skilled in navigating complex regulatory frameworks for product classification, dossier submission, and post-market surveillance. With extensive experience in various medical device categories, including In Vitro Diagnostic (IVD) products, endoscopy instruments, and implants, she excels in risk assessment and compliance management. Her commitment to ensuring regulatory alignment and ongoing product safety underscores her dedication to delivering high-quality regulatory services.Prior to joining Pure Global, Montiel held positions at ​​CNMN-IPN and CIC-IPN. She holds a Bachelor of Science in Bionic Engineering from UPIITA-IPN in Mexico.

He specializes in high-risk submissions, clinical evaluations, risk management, and global strategy for implantable devices across cardiology, orthopedics, and neurosurgery. Petiard is an experienced trainer and auditor with expertise in global regulations and standards, including the MDD and MDR, ISO 13485, FDA QSR, Brazil GMP, MDSAP, and risk management to ISO 14971:2019.Prior to joining Pure Global, Petiard held positions at Cactus Life Sciences, Emergo by UL Solutions, and Covidien (now Medtronic). He holds a degree in biomedical engineering from ISIFC in France.

His experience as a chemist, where he was managing the development of various immunoassays, lateral flow tests, and genetic tests, is the basis for his outstanding hands-on experience in writing or compiling all aspects of a Technical Documentation or FDA submission for a range of low- to high-risk IVDs, as well as medical devices. This includes deep IVD-specific expertise in companion diagnostics (CDx), in house IVD, and clinical performance study requirements under EU regulations. Dr. Eikenberg is also an expert in global medical device regulations and auditor for Quality Management Systems according to ISO 9001, ISO 13485, FDA QSR, and EU directives/regulations, such as the MDD, IVDD, MDR, IVDR. His expertise further covers strategic and regulatory compliance support for management level, such as for due diligence projects and customized training on medical device or QMS topics and regulations. Prior to joining Pure Global, Dr. Eikenberg was a Senior RA/QA Consultant, internal Auditor, and Lead IVDR Manager at Emergo by UL Solutions for 10 years. He holds a PhD in Biochemistry from the Technical University of Munich in Germany.

In her role at Pure Global, she supports clients across Europe and the US, focusing on regulatory compliance projects to ensure product quality and adherence to global standards. Her combination of scientific knowledge and technical skills is complemented by hands-on research experience in skin regeneration and regenerative medicine, including published research on skin banking. She also brings experience in front-end web development, innovative problem-solving, and effective communication to cross-functional projects, promoting collaboration among stakeholders and delivering high-impact results.Prior to joining Pure Global, Vaishna held positions at IVV Labs AB and India’s National Burns Centre. She holds a master’s degree in biotechnology from the University of Mumbai.

She has a proven track record in optimizing sales operations and elevating customer service standards through effective training, process improvements, and data analytics. Known for a strong commitment to continuous learning and adaptability, she has pursued proficiency in marketing stack technologies such as HubSpot, MS Dynamics 365, and email marketing analytics tools. D’Souza works to creatively resolve issues that enhance customer satisfaction and operational efficiency, with a history of contributing to risk mitigation and compliance initiatives.

Prior to joining Pure Global in Sweden, Rachel worked in auditing and customer support at Aditya Birla Sun Life Insurance Company Ltd. She holds a Postgraduate Degree in Management from Welingkar Institute of Management, India.

She has a proven track record for obtaining regulatory approvals with over over 300 successful registrations, including high-priority COVID-19 and monkeypox EUA applications. She develops regulatory strategies for startup and multinational companies and leads cross-functional and cross-cultural teams across diverse global markets. Zhang has designed efficient workflows and SOPs, manages service quality, and builds lasting client relationships.

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Prior to joining Pure Global, Zhang held supervisory positions at TLScontact. She holds a master‘s degree in international arts and culture management from the University of Angers in France.

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She has successfully ensured compliance for a wide range of products, including surgical instruments, critical care equipment, general hospital items, anesthetic products, gastroenterology-urology equipment, cardiology devices, and ophthalmology products. Her experience extends to project management and stakeholder coordination, which enable her proactive approach to navigating complex regulatory landscapes for various medical products.Prior to joining Pure Global, Ekaningtyas worked in regulatory affairs at PT. Sinar Roda Utama and PT. Madesa Sejahtera Utama. She holds a Bachelor of Science in Food Technology Universitas Terbuka in Indonesia.

Kin is an expert in medical device regulatory compliance and life cycle product management, with strategic expertise in home health equipment, medical tourism, and pharmaceuticals. In addition to market access, he consults with medical device companies on supply chain management, diverse portfolio compliance solutions, and product positioning. With a proven track record in leadership and compliance, he helps clients expedite approvals and ensure compliance, facilitating smoother market entry for their products.Prior to joining Pure Global, Kin was the Founder and CEO of Precious Care Co., Ltd. and Vice President at Chainavi Co., Ltd. He holds a bachelor‘s degree in business administration from Senshu University.

Clement uses his experience to craft and implement comprehensive regulatory strategies across Southeast Asia/Bangladesh/Pakistan, and specializes in renal, hospital, and vascular devices.Prior to joining Pure Global, Cheong held regulatory positions at Nipro Asia and Oculus. He holds bachelor’s and master’s degrees in biomedical sciences from The National University of Singapore.

Specializing in ISO standards (ISO 13485, ISO 14971, ISO 10993) as well as FDA, MDR, and IVDR compliance, he has successfully guided global product registrations across a range of fields, including infusion therapy, cardiovascular, respiratory care, and orthopedics. During his career, he has facilitated successful registrations worldwide for a range of products, including infusion therapy, hemodialysis, perfusion, cardiovascular, respiratory care, orthopedics, blood products, minimally invasive and more. He has trained industry professionals and provided strategic guidance for market expansion and entry strategies. He is driven to advance healthcare through cutting-edge technology and regulatory excellence. He has affiliation to many Asian Medical Device Associations with contacts around the Global Medical Device Industries.

Prior to joining Pure Global, See was a medical products consultant at Medipro Consultancyand Services. He holds an Advanced Diploma in Mechanical Engineering from Singapore Polytechnic, with certifications from City and Guilds, UK, and has worked with organizations like Baxter Healthcare, Covidien, Ohmeda, and the National University of Singapore on product development.