Rory A. Carrillo Email and Phone Number
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Revolutionizing Medical Device Innovation: From Concept to MarketAs the founder of Cosm, I'm passionate about transforming healthcare through cutting-edge medical device solutions. With over 15 years of experience, my team and I specialize in guiding innovators through the complex journey of medical device development – from initial concept to global market success.Our Expertise:🔬 Medical Device Design & Development🌐 Global Regulatory Strategy and Implementation (FDA QSR, ISO 13485, EU MDR)🤖 Artificial Intelligence/Machine Learning/Deep Learning💡 Technology Feasibility & Product Viability Assessments📊 Clinical & Usability Studies⚡️ Cybersecurity🛠️ Quality System Implementation📈 Project Management Specialties We've Supported:- SaMD and Digital Health- AI & Deep Learning in Healthcare- Virtual Reality (VR) / Augmented Reality (AR)- Wearable, Connected, And Remote Monitoring Solutions- Cardiovascular Therapies- Radiology- Intravascular & OCT Imaging- Women's Health TechnologiesWhy Choose Us?Comprehensive Expertise: From Class 2 to Class 3 devices, we ensure compliance with IEC 60601-1, 21 CFR 820, ISO 13485, IEC 62304, IEC 62366, and cybersecurity standards.Startup to Corporate Experience: We've successfully navigated both agile startup environments and complex corporate structures.Powerful Partnerships: Our network includes industry-leading experts in market research, reimbursement, and IP legal services, as well as connections to world-renowned physicians across specialties.Cutting-Edge Focus: We're at the forefront of SaMD, cloud-based imaging, AI/ML integration, and other emerging medical technologies.Let's connect and explore how we can bring your innovative medical device to life, ensuring it meets the highest standards of quality, safety, and regulatory compliance. Together, we'll shape the future of healthcare technology.#MedicalDeviceInnovation #HealthcareTech #RegulatoryExpertise #QualityAssurance #ClinicalStudies #MedicalDevices #ArtificialIntellligence #SaMD #DigitalHealth #Radiology
Cosm.
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Product Development, Quality, And Regulatory Consultant For Healthcare ProductsCosm. Sep 2012 - PresentSan Francisco, California, UsConsulting for various medical device and health-tech companies. We provide the following services for companies to help take their product from concept to commercialization:Marketing:- Market research and strategy- Growth marketing i.e. email marketing, lead generation, branding, advertisement, SEO etc.- Ads & Promo regulations training and content review- Social Media Policy creationProduct Development, Quality & Regulatory- Design and engineering services: mechanical, electrical, software, firmware- Quality System Implementation per FDA QSR and ISO 13485- Regulatory Strategy, Submissions, and Applications for any market (Pre-Submission, 510k, De Novo, Establishment Registration, CE mark, ITA [Canada] etc...)- Technical Feasibility Assessments- Usability study planning and implementation- Clinical study planning and implementation- Clinical Evaluation Reports (MEDDEV 2.7/1 Rev 4)- Technical File Creation- US FDA Agent services- IEC 60601-1 Safety assessments and guidance- Biocompatibility assessment and guidance- Cybersecurity standards and regulations- Verification and Validation strategy, planning, implementation, and execution
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Lead Systems EngineerTornado Medical Systems Jun 2011 - Jun 2012Mississauga, Ontario, Ca- Responsible for the entire development of a novel medical imaging system based on Optical Coherence Tomography (OCT) that will aid surgeons with intra-operative margin assessment during Breast Conserving Surgeries.- Lead and performed product definition activities such as Customer Interviews, User Requirements definition, Use Case Workflows, Risk Assessment, Hazard Analysis, Product Requirements definition, System Architecture definition, detailed device workflow diagrams and descriptions, and requirements analysis and management. - Lead a team of hardware and software engineers - who had no previous medical device experience - to define, design, and develop several clinical prototypes that were used in clinical experiments to understand product feasibility.- Performed system level characterization, designed and developed several system design verification and validation activities for clinical prototype systems and was responsible for several clinical systems successfully passing CSA SPE-1000 Safety Field Inspections- Responsible for creating and developing Design and Use FMEAs and collaborating with cross-functional team members (HW & SW) to ensure all aspects of the device design and use were being considered. - Managed 3rd party development partners.- Responsible for ensuring the product was in compliance to both Canadian and U.S. quality regulations focusing mainly on compliance with 21 CFR 820. - Responsible for complete product requirements and change control management.- Responsible for assessing and ensuring the product would be in compliance to IEC 60601-1 2nd and 3rd edition. - Collaborated with the Quality department to ensure the company was not only developing an quality infrastructure that complies to CSA and FDA guidelines. -
R&D Systems EngineerBoston Scientific Jun 2008 - Jun 2011Marlborough, Ma, Us- Collaborate with Marketing and other business stakeholders to develop and implement Market Specifications, Use Case Flow charts, Product Specifications, Design Functional Specifications, Design Verification Plans and Protocols for several system and sub-system level electro-mechanical medical devices. - Develop system-level benchmark testing to measure performance differences between Intravascular Ultrasound systems and custom PCs. - Design and Development of PCBA electrical constraints and layout guidelines- Maintain responsibility for managing and directing several co-development partners for the design of several PCBAs and sub-system level devices. - Provide technical support for Field Service issues and local Complaint Investigation Services ranging from troubleshooting hardware failures to debugging undetected virus issues. - Design, develop, and assess the feasibility of new technological solutions for next-generation IVUS systems. - Design, Implement and Manage a Requirements Management System using Rationale RequisitePro.- Interacted with Physicians to identify needs and problems and converted these needs into product concepts and functioning prototypes. - Developed and Performed several animal studies to assess feature enhancements and/or functioning prototypes. -
Imaging R&D EngineerBoston Scientific Sep 2007 - Jun 2008Marlborough, Ma, Us- Perform research and development for Image Improvement on iLabTM Ultrasound Imaging System- Design in-vitro test methods and models for the development of a new IVUS real-time imaging algorithm to improve lumenborder detection.- Design tissue mimicking phantoms to create a benchmark for the performance of IVUS systems.- Gather and analyze data to benchmark and compare the performance of multiple products using specifications or empirical test data.
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Manufacturing EngineerBoston Scientific Jun 2007 - Sep 2007Marlborough, Ma, Us- Performed equipment installation, operation, and performance qualifications. - Performed production support activities. Monitored process and equipment performance. - Identified and implemented process improvement activities to increase yield, efficiency, and throughput. - Developed specifications for a production process and equipment.- Trained product builders, quality control, and technicians as necessary, on equipment and documentation.- Responsible for Non-Conformance Reports (NCR), and participated in CAPA investigation and analysis. - Six Sigma Certification (Yellow Belt)
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ItApplied Biotechnology Institute 2007 - Mar 2008
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Operations EngineerSpectrasensors Jun 2006 - Sep 2006Performed equipment installation, operation, and performance qualifications. Performed production support activities. Monitored process and equipment performance. Identified and implemented process improvement activities to increase yield, efficiency, and throughput. Developed specifications for a production process and equipment. Trained product builders, quality control, and technicians as necessary, on equipment and documentation. Responsible for Non-Conformance Reports (NCR), and participated in CAPA investigation and analysis. Six Sigma Certification (Yellow Belt); Created instructions manual for natural gas analyzers which total $13 million annually in revenue. Designed, using AutoCAD, and hand-built prototypes of gas analyzers for research and development. Updated and reorganized a database of gas analyzer schematics via AutoCAD.
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Process Engineer - Co-OpTechnicolor Jan 2005 - Sep 2005Los Angeles, UsInstalled and troubleshoot software and PLC modules to increase and optimize the efficiency of the UV lamps - Resulted in an annual savings of $13,000. Designed and implemented an overheat protection circuit that was independent of the control circuitry. Performed environmental testing. Designed and implemented an on-line network that collects production information from 22 production lines. The network utilized a SQL server, an Access database, and Visual Basic Programming. Conducted an analysis on the U.V. performance of the DVD production lines. The analysis led to a more robust process, increasing the lifetime of a UV lamp, thus creating a cost initiative. Annual savings – over $50,000 a year. -
ResearcherUniversity Of Central Florida Jun 2003 - Aug 2003Orlando, Fl, UsProcessed and analyzed nano-effects of a ceramic reinforced aluminum composite with Hot Isostatic Press, Cold Press, and High Energy Ball Mill. Utilized Scanning Electron Microscope to understand the structure of the nano-sized composites. Conducted X-Ray diffraction techniques to further understand the crystallization behavior of the ceramic reinforced composite
Rory A. Carrillo Skills
Rory A. Carrillo Education Details
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California Polytechnic UniversityElectrical Engineering; Digital Signal Processing Specialty -
California Polytechnic UniversityGeneral Engineering; Biomedical Engineering
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Azusa Pacific UniversityPre-Engineering
Frequently Asked Questions about Rory A. Carrillo
What company does Rory A. Carrillo work for?
Rory A. Carrillo works for Cosm.
What is Rory A. Carrillo's role at the current company?
Rory A. Carrillo's current role is Product Development, Quality, and Regulatory Consultant for Healthcare Products | AI/ML Expert | SaMD | Wearables | Digital Health.
What is Rory A. Carrillo's email address?
Rory A. Carrillo's email address is rc****@****ail.com
What is Rory A. Carrillo's direct phone number?
Rory A. Carrillo's direct phone number is +156253*****
What schools did Rory A. Carrillo attend?
Rory A. Carrillo attended California Polytechnic University, California Polytechnic University, Azusa Pacific University.
What are some of Rory A. Carrillo's interests?
Rory A. Carrillo has interest in Triathlons.
What skills is Rory A. Carrillo known for?
Rory A. Carrillo has skills like Medical Devices, R&d, Product Development, Iso 13485, Fda, Design Control, Quality System, Engineering, Project Management, Biomedical Engineering, Cross Functional Team Leadership, Testing.
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