1161 Sawgrass Corp. Pkwy, Sunrise, FL of 6

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2 TAG3 was founded by three industry experts with a vision to offer cost-effective, streamlined medical device product design, development, quality and regulatory affairs solutions to organizations of all sizes. Our operational framework and Quality Management System are optimized to put the development of your idea or product on the fast track. The efficiency of our systems allows executing with agility, reducing risk and optimizing your budget, all within full FDA and ISO compliance. The expertise of the TAG3 team covers the full spectrum of engineering needs that arise during all phases of the design and development cycle of medical devices. TAG3 can also adapt and work seamlessly under your organization s Quality System. TAG3 Product Realization and Testing Lab, Fort Lauderdale, FL 2 of 6

3 Early-stage Concept Development Expert Team TAG3 provides early stage concept development using several rapid prototyping technologies including CAD modeling, 3D-printing, CNC machining, laser cutting, silicone injection molding, electronics design and control software development. Our Product Realization and Testing Lab (PRT) is fully equipped for prototyping and testing mechanical and electromechanical devices. We support our clients in business plan development, fundraising, intellectual property, brainstorming and writing invention records, COGS estimates, etc. 3D-printed model of consumer medical product developed by TAG3 The TAG3 team has decades of experience in the medical device industry at both start-up and established companies. Our expertise spans various technical and scientific disciplines including mechanical Engineering, Electrical Engineering, Biomedical Engineering, Biomaterials, Statistics, Microbiology, Sterilization, Regulatory Affairs, Clinical Specialists, Quality Assurance. Our team has managed or supported multiple vascular, endoscopic, urologic and general surgery products through all stages of development from concept through human-use manufacturing. We pride ourselves on delivering projects on-time and within budget. Leadership Team: Victor Gamez Scott Arp Damian Tomlin Scott has over twenty years of engineering experience in the medical device industry developing and commercially producing devices used in gastroenterology, ophthalmology and cardiology. His expertise includes product design, product development, R&D to production transfer, manufacturing process development and supply chain. Mr. Arp has also extensive expertise in machining and metrology. He has served in several start-up companies including Medcanica, Innovia and Syntheon, designing and developing products ultimately acquired by industry giants such as Medtronic, Boston Scientific, Johnson & Johnson and Stryker. He has over 10 patents, all in the medical devices arena. Victor has over twenty years of experience in Class III and II devices development, with an emphasis on vascular devices. Areas of expertise include stent delivery systems, medical device manufacturing processes, insulin pumps as well as design / process excellence (six sigma) methodologies. He has served as New Product Development Engineer for the Cardiology Division of Cordis / Johnson & Johnson and as Research and Development Engineer for the endovascular stent-grafts business of Medtronic, Inc. He has issued and pending patents in the fields of insulin infusion pump technology, pain management with electrical stimulation technology and minimally invasive vascular intervention. Damian has over eighteen years of experience as Project Manager and Product Development Engineer for Class II and III medical device products while working at Cordis Neurovascular (vascular products) and CR Bard Corporation (general surgery, urological products). He has led the development of several implantable and single-use medical device projects from concept to launch, managing cross-functional teams. He has issued and pending patents in the fields of urology and minimally invasive vascular intervention and was Associate Professor of Electrical Engineering in Electromagnetics and Biomedical Instrumentation at University of Technology, Jamaica. 3 of 6

4 Product Development / Program Management TAG3 has integrated the combined experiences of its founders and partners into a turn-key product design and development engine fully optimized to manage or support your product development efforts. Our quality system is FDA QSR/ISO compliant and designed for comprehensive medical device product development from concept through production, including: Design input generation and justification Test method development and validation Risk assessment and management Manufacturing and test equipment development and qualification Design Verification and Validation execution FDA / CE submission and response development Process development and qualification Project Management including milestone and budget tracking. Products developed by the TAG3 team include: Coronary and peripheral stents Neurovascular implants Peripheral vascular and neurovascular catheters Laparoscopic and endoscopic devices for cardiac intervention Endoscopic devices for GI intervention Insulin pump Glaucoma shunt Mesh fixation stapler for hernia treatment Ultrasonic dissection device In-vitro testing of an endovascular device at the TAG3 Product Realization and Testing (PRT) Lab Our experience with QSR and ISO regulations allows us to quickly train to different Quality Systems, for clients who already have a one in place. Printed Circuit Board designed by TAG3 for an electromechanical medical product 4 of 6

5 TAG3 offers Quality and Regulatory Affairs solutions for product, facility and quality system compliance with US and International Regulatory agencies: Quality Assurance DHF / QA remediation Audits response Risk management under ISO Service testing: catheter products, per ISO and ISO /20 including equipment for trackability force measurement Regulatory Affairs Regulatory strategy definition Predicate device characterization and testing to support regulatory submissions Prepare/support 510(k) and PMA Submissions for Class II, III devices and associated product verification/validation and process qualification activities. FDA submission responses and interaction CE mark submissions. Production Equipment, Fixtures, Molds TAG3 develops equipment, tools, fixtures and molds for production automation, efficiency and yield improvements, and operator safety. Through our partnerships with full service machining and fabrication companies, we offer very costeffective and timely development from concept to qualification. Semi-automatic precision cutting tool designed, assembled and validated by TAG3 5 of 6

6 Cleanroom Our cleanroom is ideal for low volume manufacturing of human use product. We undertake full process development and qualification activities critical to compliance with Good Manufacturing Practices, including: Equipment Installation and Operational Qualification Process Qualification Product Performance Qualification Equipment calibration / maintenance Manufacturing Support Services We undertake full process development and qualification activities critical to compliance with Good Manufacturing Practices, including: Material Testing Receiving-Inspection Offices / Conference Rooms QA Testing Labs Controlled Component and FGI Storage ISO Compliant Management System (Certification pending) Metrology Services Part inspection using TAG3's high-magnification vision and measurement system 6 of 6