Professional summary
John Ziobro is the Principal Consultant at SpectraMedEx, LLC, a medical device consulting firm specializing in strategic business development. To help grow your company, we focus on three key components of successfully launching your medical devices: 1) Quality Systems & Regulatory Compliance 2) Product Development & Project Management and 3) Global Marketing & Distribution.
SpectraMedEx's strength comes from over 30 years of hands-on medical device expertise in Executive Management, Quality and Regulatory Affairs, Project Management, Engineering, New Product Development, Sales, Marketing and Manufacturing.
Experienced with start-ups and turn-arounds; market leaders and underdogs, we value developing and building long-term trusted business Read more
John Ziobro is the Principal Consultant at SpectraMedEx, LLC, a medical device consulting firm specializing in strategic business development. To help grow your company, we focus on three key components of successfully launching your medical devices: 1) Quality Systems & Regulatory Compliance 2) Product Development & Project Management and 3) Global Marketing & Distribution.
SpectraMedEx's strength comes from over 30 years of hands-on medical device expertise in Executive Management, Quality and Regulatory Affairs, Project Management, Engineering, New Product Development, Sales, Marketing and Manufacturing.
Experienced with start-ups and turn-arounds; market leaders and underdogs, we value developing and building long-term trusted business relationships, take pride in creating company-friendly infrastructure systems and have successfully launched over 70 medical devices.
And when combined with the resources of The MedSource Coalition, we place several centuries of medical device experience at your service.
THERAPEUTIC KNOWLEDGEBASE STRENGTHS
Cardiology
Cardiovascular surgery
Dermatology
Electrocautery
Electrosurgery
Electrophysiology
Epilepsy
Hypothermia
Neurosurgery
Neurology
Physical therapy
Physiological monitoring
Ultrasound
Specialties: Medical Device Consultant, Domestic & International Medical Device Consulting, Interim Executive Management, Product Management, Market Management, Project Management, Quality & Regulatory Compliance, FDA, MDD, CMDCAS, PAL, TGA and KFDA Submissions, Technology Evaluation, Design Control, Infrastructure Systems, cGMP & ISO 13485 Quality Systems, ISO 14971 Risk Management, Distributor Networks, Pricing Strategies, Competitive Analysis, Business Plan Development, Technical Writing, Assurance Cases.
Clients
• Acuforce International, Inc.
• Advanced Powder Products
• Airlet Medical Systems, LLC
• Asenso Health
• Benson Medical Instruments
• BioScience, SRL
• Biomedical Devices of Kansas
• Blackrock MicroSystems
• Blackrock Neuromed
• CaP Biomaterials
• Cerebotix
• CytoCore
• Cytophil
• DMP
• EcoDoc
• Electro-Cap
• Enhancement Medical
• Essential Pharmaceuticals
• Frank Mayer and Associates
• GrandCare Systems
• High Tech Sports Science
• Honeywell HomMed
• Hospira
• Huot Instruments
• Innovative Products
• International Plastics
• Isomark, LLC
• EpiGuard USA, LLC
• MEDevices, Inc.
• Medical Thermodynamics
• MCW: Technology Development
• Moving Life
• MPE
• NaviTech Research
• Newcomer Supply
• Navimetrics, SL
• Novian Health, Inc.
• Peak Surgical
• Preferred Instruments
• Trans Med Corporation
• VibeTech
• Acuforce International, Inc.
• Advanced Powder Products
• Airlet Medical Systems, LLC
• Asenso Health
• Benson Medical Instruments
• BioScience, SRL
• Biomedical Devices of Kansas
• Blackrock MicroSystems
• Blackrock Neuromed
• CaP Biomaterials
• Cerebotix
• CytoCore
• Cytophil
• DMP
• EcoDoc
• Electro-Cap
• Enhancement Medical
• Essential Pharmaceuticals
• Frank Mayer and Associates
• GrandCare Systems
• High Tech Sports Science
• Honeywell HomMed
• Hospira
• Huot Instruments
• Innovative Products
• International Plastics
• Isomark, LLC
• EpiGuard USA, LLC
• MEDevices, Inc.
• Medical Thermodynamics
• MCW: Technology Development
• Moving Life
• MPE
• NaviTech Research
• Newcomer Supply
• Navimetrics, SL
• Novian Health, Inc.
• Peak Surgical
• Preferred Instruments
• Trans Med Corporation
• VibeTech
