Consulting Services
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Biomaterial selection, qualification, and product testing assessment
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Biocompatibility testing protocol, risk assessment, and evaluation report
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Chemical characterization test plan for product submissions
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Standards gap assessments
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FDA, MDR, and PMDA biological safety testing justifications and responses
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Root cause analysis for biocompatibility test failures
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Change assessment to material, supplier, manufacturing, and process
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Corrosion and degradation analysis
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Failure analysis
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Technical writing, rationales, reports, and position papers​
Jeffrey S Blanzy, MS, PhD
President and CEO of Blanzy Biotech
Dr. Jeffrey Blanzy is President and CEO of Blanzy Biotech. In this role, he is a principal consultant performing Biological Safety Evaluations of medical devices. He has 20 years of industry experience in medical device design, design controls, and product submissions. He has worked for or consulted with several medical device companies in R&D and Biocompatibility. These companies include Abbott, Stryker, BD, W.L. Gore and Vomaris Wound Care. He is an inventor of biomaterials. He has experience developing FDA Master Files for metal alloys and has won the ARCS Foundation Scholar Award for synthesizing an implantable, temperature-responsive, radiopaque, neurovascular embolic hydrogel as part of his PhD research.
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His consulting practice ensures that product submissions conform to all relevant standards and are characterized utilizing state-of-the-art testing techniques required to gain clearance for class I-III medical devices. He can eloquently craft rationales, protocols, and reports for product submissions and can develop biological risk assessments in accordance with the ISO 10993 standards. He has successfully defended and received numerous product clearances with regulatory bodies including FDA, EUMDR, PMDA, and NMPA.
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His firm offers a personalized service, customized to client’s individual needs. He encourages you to schedule a 15-minute free consultation where he will review your project and offer guidance on what is needed for approval.
