Expert Details

Expert in Medical Device Regulatory Affairs: CE (Canada) and FDA

Expert ID: 733346 Connecticut, USA

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Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall, and has had meeting with regulators for pre-submission. Also he has experience with clinical trial applications and IDE.

Expert's medical device experience includes:

Catheters/Stents: IV administration sets, peripheral perfusion/infusion catheters, coronary perfusion/infusion catheters, thoracic catheters, chest drains and blood bags, embolectomy catheters, thrombus aspiration catheters, PTA, PTCA, CVC, ECMO, retrograde and antegrade hemodialysis catheters, urethral and ureteral catheters/stents, insulin administration, Closed System drug Transfer Devices (CSTD), non-roller cardiopulmonary bypass pumps and catheters, coronary and peripheral BMS, peripheral covered stents, aortic covered stents, DES, ureteral stents, urological stents, esophageal stents, intracranial aneurysm stents, pericardium covered stents, vascular grafts and vascular grafts with helix or nitinol reinforcement, and vascular patches.

Biomaterials: bone void fillers, resorbable implants, hydroxyl appetite, hyaluronic acid, dental impression materials, PEEK, calcium carbonate, Beta TCP, imaging contrast agents, hydrogel dressings, lubricious coatings, artificial saliva, contact lenses and contact lens solutions, antimicrobial coatings, antithrombotic coatings, IIb/IIIa inhibitors, mTOR inhibitors, and omega3 coatings, injectors and pens, antimicrobial wound cleanser and bandages.

Orthopedic/Dental: ACL/PCL screws, suture anchors, tacks, staples, spinal cages, trauma plates and screws, CMF, approximation pins and rods, dentures, veneers, dental implants/abutments, impression material, autoclave equipment, dental units, limb lengthening systems, and intra-oral x- Expert equipment.

Accessories: tunnelers, suture wings, convenience kits, stylets, peel away dilators, cannulas, scalpels, suture, guidewires, sheathes, extension sets, repair kits, luer valves, needle/syringes, blood vacuum tubes, needle safe devices, O2 regulators, radiation therapy patient positioning systems, radiation range compensators, sterilization biological and chemical indicators, and fiber wire docking stations.

Hardware/Software: neonatal clinical trial software, firmware, RIS software, image repository software, ECG analyses software, TENS, MIRS, MMA, MDDS, EMC therapy, PACS, stereotactic tracking system, stereotactic software, patient monitors, ventilators, lift beds, TMS (transcranial magnetic stimulator), active tinnitus implants, Holter monitors, phototherapy devices, data fusion software, hyperbaric chambers, autoclave sterilizers, powered muscle stimulators, cryosurgical units, MDM workflow software, Doppler and GPS ultrasound scanners, GPS needle sensors, vascular access needles, RF, nerve block needles, fiber optical lasers, neuron stimulators, and therapeutic massagers, MIMS, viewing monitors, body contouring devices.

Reusables: nasopharyngoscope, colonoscope, colposcope, neurological endoscope, sinuscope, arthroscope, and laparoscopes, instruments, tunneler rods, irrigation systems, therapeutic mattresses, OB/GYN scopes, patient cables and electrodes, scooters, vein graft tunneling systems, confocal optical imaging devices, and cannulae, 3DHD endoscopes, IR fluorescence and Indocyanine green endoscopes, measuring microscopes.

General Surgery: surgical film, pressure mattresses, cryo-biopsy needle, surgical mesh, plugs, anal fissure drug suppository and delivery plunger, anorectic Nifedipine CTD, red light therapy dermatology lasers, surgical lasers, and Continuous Low Irradiance Photodynamic Therapy (CLIPT) for phototherapy drug activation, collection and transport media, disinfecting swabs and wipes, gastrostomy tubes.

IVD: HIV antibody test, chemo urine culture test kits, pregnancy tests, and others.

Expert has consulted to Abiomed, Carl Zeiss, Dell, Kaneka, Karl Storz, Maquet, McKesson, Mitsui, Proctor & Gamble, Smith and Nephew, and Terumo, among many other clients.

Expert may consult nationally and internationally, and is also local to the following cities: New York, New York - Yonkers, New York - Newark, New Jersey - Jersey City, New Jersey - Paterson, New Jersey - Bridgeport, Connecticut - New Haven, Connecticut - Worcester, Massachusetts - Springfield, Massachusetts - Providence, Rhode Island

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Education

Year Degree Subject Institution
Year: 1993 Degree: BS Subject: Electrical Engineering Institution: Werner Siemens College

Work History

Years Employer Title Department Responsibilities
Years: 2008 to Present Employer: Undisclosed Title: Chief Regulatory Officer Department: Licensale Inc Responsibilities: Expert manages and performs all regulatory applications and projects for clients.
Years: 2008 to 2012 Employer: Maquet-Getinge Group Title: Director of Regulatory Affairs Department: Atrium Medical Corporation Responsibilities: He managed and performed all regulatory applications and projects for products.
Years: 2006 to 2008 Employer: Spire Corp Title: Director RA/QA Department: Spire Biomedical, Inc Responsibilities: Expert managed and performed all regulatory applications and projects for products. He also manages quality system.
Years: 2000 to 2006 Employer: TESco Associates, Inc. Title: Director RA/QA Department: Responsibilities: Expert managed and performed all regulatory applications and projects for products; he managed quality systems as well.
Years: 1999 to 2000 Employer: Siemens Medical Title: QA TEST ENGINEER Department: DuPont Chemistry Systems Responsibilities: He managed quality and regulatory compliance for STAR product lines.

Language Skills

Language Proficiency
German Fluent

Fields of Expertise

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