Expertise
Our experts can help you understand how to the navigate regulatory compliance requirements that are applicable to your technology. Our services are particularly suited to small companies or projects that are moving rapidly to get a medical device to market. Our goal is to allow your team to focus on innovation and business operations while we seamlessly take care of compliance.
• Deep industry knowledge and expertise in technology and market trends
• Tools and methods for aligning organizational and business strategy with compliance needs
• Internationally recognized expertise in risk management, liability, and crisis management.
• Familiarity with multi-cultural business requirements and international regulations
• Established reputation in international regulatory and quality standards and policy making bodies
CEO: GEETHA RAO
Dr. Rao is a strategic advisor to medical device, healthcare, and philanthropic organizations, addressing issues for high-risk technologies, including medical devices, health IT, and connected health systems. Her particular focus on agile quality management and compliance strategy for rapid commercialization. She specializes in guiding companies in achieving lean and cost-effective quality and regulatory compliance.
She also supports clients with regulatory legal problem-solving related to submissions, contractual issues in quality and risk, audit findings, and adverse events. She has established, audited, remediated, and maintained quality system processes and documentation for clients.
She is an internationally recognized expert in risk management and supports international regulation and policy bodies, and standards development organizations with establishing standards and guidance documents in quality and risk management. Specifically, she leads standardization efforts for interoperable medical systems.
She has addressed numerous industry forums and the press on issues of emerging health technologies and innovation trends for connected medical technologies.
CLIENT SERVICE HEAD: ESTER CARRASCO
Ester is a medical device regulatory and quality management compliance specialist. She supports clients with agile quality management systems implementation, with a special focus on start-up companies that require significant support and training. She has experience with many key aspects of quality management, including document and design controls, design transfer, supplier controls, management reviews, and internal audits. She has also prepared design dossiers and has previous design experience with a range of medical devices, developing product features, identifying required testing, and preparing user documentation.
Ester is also an experienced regulatory researcher supporting regulatory strategy for platform technologies and preparing regulatory submissions, including FDA 510(k) Submissions, Pre-submissions (Q-Subs), De Novo, and Breakthrough Device Designation Requests.
ENGINEERING SPECIALIST: LU WANG
Dr. Wang is a general specialist, out of box thinker, serial entrepreneur, and highly effective and efficient problem solver. He spent 6 years at Medtronic where, among other things, he worked on algorithm design, electrochemistry, and various collaborative projects with marketing, clinical research, and manufacturing. Previously, he has served as principal engineer at Neurolink Medical, Inc and Incube Labs, LLC leading projects in epilepsy, transdermal drug delivery, electrostimulation of cells, cancer therapy, and bioreactor engineering. He spent the ensuing years as an executive in the biotech industry, especially in immuno-oncology and AI-powered drug discovery. He has also drafted clinical protocols and grant applications and performed regulatory due diligence.
COMPLIANCE SPECIALIST: AMY LUTTON
Amy holds a bachelor's degree in English, experience in administrative support and supports the team with document preparation, proofreading, organization and her ability to learn and adapt to new technologies. She is currently learning and expanding her knowledge in the field of medical device regulatory and quality management compliance. She applies her background to help navigate the complex regulatory landscape of medical devices.
BUSINESS MANAGER: CARLOS SIGUENZA
Carlos is a Business Administation graduate, with experience working as an administrative and remote assistant for different industries such as NGOs, consulting, and property management businessesHe helps the team with contract, task,,email management and implementing high-level administrative skills in the field of regulatory and quality management compliance.COMPLIANCE SPECIALIST: GENESIS SERRANO
Genesis is a Registered Nurse with experience providing care to patients in hospitals, clinics and other healthcare settings. As a nurse she can provide valuable insight into the engineering of medical devices based on her experience using them in the clinical setting. Given her medical perspective, she supports clients with conducting usability testing on their devices, developing and executing test plans, analyzing test result and providing recommendations for device improvements.