Providing the Best Regulatory Solution with
Quality Assurance & Data Security

Our management team is composed of qualified and experienced professionals from a variety of backgrounds, collectively bringing a wealth of experience in the Medical Device, Pharmaceuticals, Food, and Cosmetic industries. They blend strategic vision with regulatory compliance expertise. Dedicated to excellence, they guide our company to success with effective leadership, collaboration, and adaptability.

DIRECTOR, I3CGLOBAL US INC

Binoy J. Joese is an esteemed healthcare professional with over two decades of experience, currently serving as the Director of I3CGLOBAL US. With a solid educational background in nursing and a master’s degree, Binoy excels in blending clinical expertise with strategic management to elevate healthcare standards and operational efficiency.

 

Prior to his current role, Binoy held significant positions at IBM Watson Healthcare and GE Healthcare, where he was instrumental in integrating advanced technologies and data analytics to improve patient outcomes. His tenure at the University of Illinois further solidified his reputation as a leader in healthcare education and practice.

 

Binoy’s extensive experience and dedication in Medical Device Quality management and GMP make him a pivotal asset to I3CGlobal US. His leadership continues to drive the organization’s mission of providing cutting-edge regulatory and quality assurance solutions in medical device regulations for Europe, USA, and Canada.

DIRECTOR, Acting UKRP

Luke Fernandez, who joined us in 2018, brings a wealth of experience in medical device CE and UKCA regulations. With over 15 years dedicated to the sales and distribution of medical devices, Luke has developed a robust understanding of regulatory compliance. Holding a master’s degree in computer applications, he has an impressive track record of working across organisations in India, the USA, and the UK. This diverse background has enriched his perspective and honed his expertise in the global medical device market.

 

Luke’s international experience has endowed him with valuable regulatory compliance insights, particularly in the areas of sales and MHRA regulatory documentation. His deep knowledge of CE and UKCA regulations, combined with his practical experience, makes him an indispensable member of our team. Luke’s adeptness in navigating complex regulatory landscapes ensures that our services are both compliant and efficient, meeting the rigorous standards set by the industry.

 

With Luke’s expertise, our UKCA, UKRP, and MHRA services consistently meet the highest standards, driving our mission forward with excellence. His dedication to maintaining regulatory compliance and his ability to manage intricate documentation processes play a crucial role in our success. Luke’s contributions not only strengthen our UKCA / MHRA regulatory services but also reinforce our commitment to delivering reliable and high-quality solutions to our clients.

DIRECTOR, Acting EU Representative

Joe Kumar is a science graduate with over 18 years of extensive experience in the import, export, and sales of medical devices across Europe for major multinationals. His career has been marked by a deep engagement with the European regulatory landscape, making him a vital asset to our team. Joe’s expertise spans a range of critical areas, including EU regulations that cover European authorised representatives, EUDAMED, competent authority regulations, and free sale certification. His comprehensive understanding of these areas ensures that our operations are always aligned with the latest regulatory requirements.

 

In addition to his regulatory expertise, Joe’s experience as an authorised representative for over 240 foreign manufacturers and importers highlights his exceptional ability to manage and support a diverse client base. His role in representing these manufacturers and importers has equipped him with unparalleled customer-handling skills and an acute awareness of the nuances involved in medical device sales and compliance. Joe’s ability to navigate complex regulatory environments and provide tailored support to clients underscores his value to our team.

 

Joe’s contributions significantly enhance our ability to provide top-tier EAR services. His deep understanding of EU regulations and his practical experience in acting as an authorised representative ensure that our services are not only compliant but also efficient and reliable. With Joe on our team, we are well-equipped to support our clients in navigating the EU MDR and IVDR challenges of the device industry, consistently delivering high-quality, compliant solutions that drive our mission forward with excellence.

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Balint Teodor is a seasoned professional with 34 years of experience in the field of technical documentation review for medical devices. Based in Hungary, Balint has built a distinguished career as an Ex Notified Body Technical Reviewer, specializing in the meticulous evaluation of medical device technical documentation. His extensive experience spans multiple prominent organizations, including BSI, SGS, JBL and SISMA, where he has honed his expertise and contributed to the advancement of medical device safety and compliance.

 

Throughout his career, Balint has demonstrated exceptional proficiency in reviewing technical documentation for non-active medical devices, adhering to the stringent requirements of both the Medical Devices Directive (MDD) and the Medical Device Regulation (MDR). His comprehensive understanding of regulatory standards and his ability to assess devices of any risk class have made him a trusted authority in the field. Balint’s meticulous approach and keen attention to detail ensure that every device he reviews meets the highest standards of safety and efficacy.

 

Balint’s deep knowledge extends to the I3CGLOBAL team in identifying complex regulatory hurdles, troubleshooting, and guiding the internal team to overcome challenges. His services are also beneficial in solving and justifying complex queries raised by notified bodies. Based in Hungary, Balint Teodor continues to contribute to the field with his unparalleled expertise and unwavering commitment to excellence.

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Our technical team comprises a dynamic group of QARA professionals with strong expertise in regulatory frameworks spanning the USA, UK, EU, and MHRA. They specialize in product regulatory compliance and system compliance, encompassing medical devices, In-vitro diagnostic devices, pharmaceuticals, as well as the food and cosmetics industries, along with adherence to GMP standards. Fueled by a passion for excellence and a commitment to collaboration, they propel our company’s technical initiatives and services forward, guaranteeing early certifications and approvals.

TECHNICAL DIRECTOR

Soio George brings over 26 years of extensive experience in regulatory compliance. With strong manufacturing and documentation experience combined with academic degrees in pharmacy and business administration, makes him a strong man to lead the entire technical consulting team

 

Drawing from extensive experience in the production and quality control departments of renowned pharmaceutical giants including Torrent, Microlabs, Geltech, and Medreich, Soio has acquired invaluable expertise in manufacturing, QC, and navigating regulatory frameworks such as US FDA, MHRA, and TGA inspections. His deep understanding and hands-on experience have proven instrumental in navigating intricate regulatory landscapes with finesse. Soio’s proficiency in designing world-class facilities underscores his commitment to upholding compliance standards at every level.

 

Soio’s leadership as a technical head has earned him a respected reputation in the medical device industry, making him a valuable asset to any organization committed to maintaining the highest levels of product integrity and regulatory adherence.

MANAGER – US FDA Compliance

Beena is a highly skilled Manager with a wealth of expertise. Holding a postgraduate degree in Microbiology, she has 22 years of experience in the pharmaceutical and medical device manufacturing and consulting industry. Her career is marked by significant contributions to Quality Control (QC) and Quality Assurance (QA), ensuring products meet stringent quality and regulatory compliance.

 

In her current role, Beena focuses on US FDA Registration, Listing, and Label Review. Her meticulous attention to detail and thorough understanding of FDA regulations make her an invaluable asset to the team. Beena’s responsibilities include overseeing the registration and listing of pharmaceutical, Food and cosmetic products with the FDA, ensuring compliance with all applicable regulations, and reviewing product labels for accuracy and regulatory adherence. Her expertise ensures that our customer’s products are properly registered and labelled, facilitating smooth market entry and maintaining compliance with US FDA guidelines.

 

Beena’s dedication to quality and regulatory compliance, combined with her scientific expertise and industry experience, makes her a key member of our management team. Her leadership in QA and QC processes ensures that all our customers meet the highest standards of quality, reinforcing our commitment to excellence and reliability in the market.

MANAGER – EU-UK Compliance

Asha Johnson is an experienced and detail-oriented Medical Devices Regulatory Affairs professional with over 7 years of expertise in navigating the regulatory landscape of medical devices and Invito diagnostic devices. Skilled in preparing and maintaining comprehensive technical documentation for CE marking, clinical evaluations, risk management, and biological evaluations, compliant with the latest EU Regulations.

 

Asha has consistently demonstrated her capability in steering EU and UK regulatory projects, liaising effectively with notified bodies and leading teams towards the successful registration and compliance of products. Her exceptional analytical prowess, coupled with her adept problem-solving skills and comprehensive understanding of regulatory requirements, underscores her commitment to driving continuous improvement and safeguarding end-users safety.

 

Educationally grounded with a Master of Science in Biomedical Engineering from New Jersey Institute of Technology (NJIT), USA, and a Bachelor of Technology in Biomedical Engineering from the University of Calicut, India. This strong academic foundation is complemented by numerous certifications in regulatory affairs and project management, including RCC – MDR Certified Professional (RAPS) and Google Project Management.

Since joining our team in 2017, Arun has consistently proven himself to be an invaluable asset, boasting over 15 years of unparalleled expertise in quality management systems (QMS). A computer science graduate, his professional journey commenced in the dynamic field of aerospace quality control, where he honed his skills and laid the groundwork for his illustrious career. Through his dedicated efforts, Arun has amassed a wealth of experience, navigating the intricate landscapes of AS 9100, ISO 13485, and 21 CFR 820 regulations with finesse and precision.

 

Arun’s proficiency extends far beyond mere technical knowledge; he is a seasoned strategist and problem solver, adept at tailoring MDQMS implementations to the specific needs of both the manufacturing and service industries. Additionally, he ensures compliance with medical device regulations by navigating the intricacies of IEC 62304, applicable to software as a medical device and software-integrated medical devices.

 

In his role as a team lead, Arun’s commitment to customer training, internal audits, interactions with process owners, and decision-making is exemplary. His exceptional skill in forecasting potential nonconformities and effectively resolving them is truly remarkable.

TEAM LEAD – FDA 510(K)

Sakthileela Nagaiyan is an experienced and meticulous professional specializing in Medical Devices Regulatory Affairs, with over 7 years of experience in the medical device manufacturing industry. She particularly excels in handling Class II and III implantable, electrical and software medical devices. Driven by a profound passion for technology, she holds a bachelor’s degree in information technology and a Master’s degree in Computer Science Engineering from Anna University, India. Sakthileela began her career as a software developer in an implantable medical device manufacturing company, further solidifying her technical expertise.

 

Her academic background, acquired skills, and comprehensive knowledge of regulatory requirements and various IEC and ISO standards such as IEC 62304, IEC 82304, ISO 60601, and IEC 62366 enable her to proficiently navigate the regulatory framework for diverse medical devices, including active and implantable devices. She excels in preparing and compiling coherent technical documentation, ensuring compliance and quality in every project.

 

Sakthileela has demonstrated her competence through successful submissions, analyzing appropriate pathways such as pre-submissions, De Novo, and 510(k) via traditional or abbreviated types. She collaborates effectively with clients, reviewers, and team members, ensuring smooth and timebound 510(k) clearance.

Amrutha Rai’s expertise in healthcare is impressive, particularly her extensive experience in both pharmaceutical technology and medical device environments over a decade. Her leadership in project coordination and execution at I3CGLOBAL US showcases her dynamic abilities. With a master’s degree in Pharmaceutical Technology and an internship in the Indian Institute Of Chemical Technology (CSIR-IICT), Telangana, Hyderabad, she possesses a strong academic foundation.

 

Her proficiency spans various areas, including analytical instrument handling, formulation, and drug development processes. Her former experience in instrumentation handling, bioanalytical studies, clinical trials data development, and SOP preparation underscores her versatility. Additionally, her certification and training in the ISO 10993 series demonstrate her commitment to regulatory compliance and safety standards.

 

Notably, her understanding of regulatory requirements such as 510K, DeNOVA, and PMA, coupled with her ability to implement regulatory strategies effectively, is commendable. Her contributions to high-profile projects for 510k submissions and clearance of diverse devices like SaMD, orthopedic implants, sutures, catheters, and drug-device combinations highlight her strategic acumen and regulatory expertise. Amrutha’s energy and competence align with I3CGLOBAL US’s vision of providing credible regulatory services in medical device regulation. Her multidimensional skill set and dedication make her a valuable asset to the organization’s success.

TEAM LEAD – Clinical Evaluation

Sadaf Parween is acknowledged as a proficient specialist in the field of MDR clinical evaluation report documentation. Sadaf’s function is significantly enhanced by her profound comprehension of scientific principles, which she has acquired through her master’s and five years of clinical writing exposure.

 

Her significant experience exploring databases such as PubMed, PDQ evidence, Europe PMC, and Cochrane for complete literature reviews adds to her ability to clearly and effectively summarize complex clinical results. Sadaf’s ability to critically evaluate scientific literature and study techniques ensures that clinical assessments are based on evidence. Sadaf’s experience ranges from MDR Articles 83-90 to MDCG standards. She specializes in PMS tasks, which include collecting, organizing, and managing post-market data such as adverse event reports and complaints.

 

Sadaf has a reputation for being a dedicated leader who can successfully negotiate challenging regulatory environments, which makes her a priceless addition to I3CGLOBAL. Her team consistently meets and surpasses notified body challenges because of her methodical approach and dedication to quality, which has greatly aided in the fast approval of technical documentation and early CE Certification.