Meet the Team Behind Our Trusted Solutions

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.

With deep technical expertise in personalization, computer vision, and natural language processing, Chen has built and scaled end-to-end machine learning systems that power user experiences, optimize engagement, and accelerate business growth. Chen has a proven track record of managing distributed teams, fostering a culture of experimentation, and delivering scalable, data-driven solutions from scratch.

Prior to joining Pure Global, he served as the founding machine learning engineer and later Director of Engineering at Tubi TV, where he led the development of core recommendation engines, experimentation platforms, and international personalization strategies for a platform serving over 100 million users. He holds a Master of Computational Data Science from Carnegie Mellon University and a Bachelor of Software Engineering from Tsinghua University in Beijing.

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.

She specializes in product registration and regulatory compliance with ANVISA, INMETRO, ANATEL, CE Marking, GMP, ISO 13485, and ISO 9001. At Pure Global, she works on medical device registration and quality system implementation projects in Brazil. Her expertise includes a wide range of medical technologies, as well as technovigilance, audits, and certification maintenance.

Prior to joining Pure Global, Bastos held senior roles in regulatory and quality management at Brazilian medical device manufacturers. She holds a degree in pharmacy from Universidade Cruzeiro do Sul and an MBA in Business Management from Universidade de São Paulo, with additional specializations in regulatory affairs and quality systems.

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 bachelor‘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.

She specializes in regulatory documentation management, workflow standardization, and compliance with INVIMA requirements, as well as international registration frameworks. Velilla has led regulatory operations and business strategy initiatives, designing and implementing systems to automate and standardize regulatory processes, maintain high-precision documentation for INVIMA and UDI-DI registrations, and coordinate activities between manufacturers, distributors, and regulatory authorities. In her role at Pure Global, she supports regulatory submission projects in Colombia, coordinating timelines, overseeing deliverables, and ensuring that documentation meets applicable regulatory standards.

Her background also includes senior leadership roles in marketplace management and large-scale project execution. She holds an MBA from Universidad de los Andes and a degree in Economics from Pontificia Universidad Javeriana.

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.

He has hands-on experience detecting adverse drug reactions, preparing regulatory dossiers, and overseeing medical device safety through technovigilance and pharmacovigilance reporting. Carlos is skilled in navigating both local and international regulations, including those established by COFEPRIS, the FDA, and the EMA, for both medical devices and pharmaceuticals. His background also includes experience with high-cost medicines, controlled substances, and cold chain medicines.

Prior to joining Pure Global, Carlos held positions at DEWIMED SA and Hospital Star Médica Hip. He holds degrees in Pharmaceutical Chemistry and Biology from Universidad La Salle in Mexico.

She specializes in regulatory documentation preparation, medical device validation, and compliance with Mexican and international frameworks, including COFEPRIS requirements, ISO 13485, MDR, FDA, and NOM-24. In her role at Pure Global, she supports regulatory submission projects in Mexico, coordinating timelines, managing client communication, and ensuring that technical documentation meets applicable regulatory requirements.

Prior to joining Pure Global, Maria worked in medical device distribution and healthcare solutions. She holds a bachelor’s degree in biotechnology from Universidad Anáhuac México.

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.

She has a proven ability to identify emerging trends and capitalize on market opportunities. Melanie is passionate about building and maintaining customer relationships and consistently exceeds sales targets by putting the customer in the centre and delivering tailormade solutions. Melanie is a strategic thinker with a proven track record of identifying and closing deals. With a deep understanding of customer needs, she spearheads business development initiatives to drive sustainable growth.

In her role at Pure Global, she is focused on establishing Pure Global in the European market.

He excels in driving growth and innovation while identifying business opportunities, forging partnerships, and expanding markets. He leads global teams, develops regulatory strategies, and launches digital platforms, with a strong focus on global market access and compliance. He is dedicated to implementing innovative digital and AI solutions that improve the quality and efficiency of services offered to clients.

Prior to joining Pure Global, van der Woude was Chief Operating Officer at Emergo Group and, later, Director and General Manager at Emergo by UL. He holds a Master of Arts in Business Economics from The University of Groningen in The Netherlands.

He excels at developing and executing successful go-to-market strategies and nurturing key relationships in multicultural environments. Azur has successfully driven growth across diverse sectors, including medical technology and global trade. He focuses on truly understanding the needs of the customer and executing tailored strategies. Azur is also passionate about AI and its potential to revolutionize healthcare solutions, bring medical innovations to the global market, and simplify access for manufacturers, distributors, and patients.

Prior to joining Pure Global, Azur worked at Emergo by UL and Xindao, where he played a pivotal role in expanding market presence and delivering tailored solutions to clients. He has studied Business Administration and Management at Kristianstad University in Sweden.

Her legal background combined with expertise in EU MDR, IVDR, and related legislations and compliance areas per applicable market make Giulia an asset to device companies seeking market access across Europe. She manages technical file reviews, supports ISO 13485 audits, coordinates European Authorized Representative services, and advises clients on the impact of regulatory changes. Fluent in Italian and English with strong legal researching skills, she excels at navigating complex regulatory requirements, facilitating communication between clients and authorities, and providing end-to-end regulatory assessments.

Prior to joining Pure Global, Giulia was a regulatory affairs consultant and European Authorized Representative service coordinator at MedEnvoy. She holds a Master of Laws (LLM) in European Law from Universiteit Leiden.

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.

He specializes in FDA 510(k) submissions, ISO 13485 quality management systems, and manufacturing engineering. He has led more than 30 successful 510(k) submissions across diverse medical device categories, showcasing technical leadership in navigating complex approval processes. Leveraging AI-driven tools, he streamlines regulatory workflows, improving documentation accuracy and accelerating the delivery of medical technologies to market. This approach enhances compliance efficiency and supports public health by expediting the approval of safe medical innovations. Trilingual in English, Mandarin, and Cantonese, Jarvis communicates effectively with international clients and regulatory authorities.

Prior to joining Pure Global, Jarvis held engineering and research roles at Providence Enterprise Limited and the Chinese Academic of Sciences. He holds two engineering degrees in STEM major from Arizona State University.

He specializes in regulatory strategy development, clinical trial management, and quality system implementation across a wide range of technologies, including surgical robotics, radiology systems, wearable devices, and AI-based software. Yan has successfully guided start-ups and multinational manufacturers through regulatory pathways for FDA, EU MDR, and China NMPA. At Pure Global, he provides strategic regulatory consulting that helps clients navigate international compliance challenges, optimize submissions, and accelerate time to market.

Yan’s background includes leadership roles at Medtronic, Varian, Brainlab, and Qserve Group. He holds degrees in Pharmacy and International Trade and is a certified member of the Regulatory Affairs Professionals Society (RAPS).

He has planned and executed numerous international registration and admission projects, providing pre-sales guidance and after-sales support to over 100 medical device companies. He has deep expertise in global market trends and regulatory compliance policies across various countries. His ability to deliver tailored compliance solutions, especially for small and medium-sized enterprises, has contributed significantly to raising industry standards. Before joining Pure Global, Chen was instrumental in building China’s Unique Device Identification (UDI) traceability system and facilitated alignment with the National Medical Products Administration's UDI requirements for over 300 companies.

At Pure Global, she supports global clients in navigating Indonesian medical device regulations and go-to-market strategies. Her work includes aligning commercial objectives with regulatory and import requirements, strengthening local partnerships, and supporting shipment compliance processes.

Prior to joining Pure Global, Ramadhani held marketing communications roles at institutions including PT Bank Rakyat Indonesia and Asosiasi Dana Pensiun Indonesia. She holds a bachelor’s degree in communication from Universitas Ahmad Dahlan and is certified in digital copywriting and TOEFL ITP.

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.

Her regulatory expertise includes managing product registrations, renewals, and post-approval changes in accordance with Thai FDA and international regulations, with technical expertise in hospital and renal products and cardiovascular and endovascular devices. Nuch has a strong background leading internal audits and teams, handling regulatory documentation, and ensuring product alignment with global standards and regulations, including ISO 14971 and the EU Medical Devices Regulation (MDR).

Prior to joining Pure Global, Nuch held positions at Nipro Sales, True Healthcare and Franco-Pacific. She holds a Master of Business Administration from The National Institute of Development Administration (NIDA) in Bangkok, Thailand.