11/05/2026 updated

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Medical Device Consulting and R&D Expert

Herzelia, Israel
Worldwide
PhD MBA
Herzelia, Israel
Worldwide
PhD MBA

Profile attachments

Amir_Kraitzer_Consulting_One_Pager.pdf

Material Science and Selection
Expertise in metals, metallic device components, polymers including polyurethane, silicone, TPE and nylon, biodegradable and bioabsorbable materials, bone-graft biomaterials, coatings, electrospun fibers, filtration materials and carbon-nanotube cartridges.

Medical Device R&D and Process Development
Extensive experience in product development from concept to production, including process development, failure investigation, manufacturing yield improvement, and transfer to manufacturing for medical devices.

Regulatory and Quality Assurance
Proficiency in regulatory test planning, risk assessment, ISO 10993 biocompatibility work, standards-based test plans, validation plans, and material-change testing for engineering change orders.

Six Sigma Application
Application of Six Sigma methodology in manufacturing environments, achieving significant cost reductions in large-scale production plants.

Electrospinning and Coating Technologies
Technical work in electrospinning and material selection, coating approaches to reduce clot formation, and humidity control to address inconsistent coating results.

Biocompatibility Testing
Hands-on experience with ISO 10993 biocompatibility testing, particulate testing, and biological safety assessments for medical devices.

Clinical and Surgical Support
Support of surgeons during clinical studies, including building production lines and providing on-site assistance for implant-related procedures.

Injection Molding and Packaging
Experience in packaging and silicone/TPE injection molding, as well as soap-rinse testing and filtration-material selection against clogging.

Degradation and Mechanical Testing
Execution of mechanical and degradation testing for biodegradable surgical anchors and other implantable devices, including pill design for pressure resistance and degradation time.

Languages

EnglishNative speaker

Project history

Medical Device Consultant

Resonetics / STI
Applied Six Sigma in a 200-person plant, achieving a reported 30% cost reduction in stent manufacturing.

Medical Device Consultant

Tel Aviv University
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Via Surgical
Work across separate programs included initial development, material selection, manufacturing, standards-based test plans, mechanical and degradation testing, biocompatibility and reporting for biodegradable surgical anchors.

Medical Device Consultant

Voll Medical
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Active Implants
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Allium
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Angie Tech
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Augma Biomaterials
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Beck Medical
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Body Vision
Consulting engagement in medical device development and R&D.

Medical Device Consultant

CartiHeal
Investigated implant failures, identified hydrophobic units and developed a QC rejection screen. Built the production line and supported surgeons during clinical studies for cartilage repair implants.

Medical Device Consultant

Clalit Health Services
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Eitan Medical
Consulting engagement in medical device development and R&D.

Medical Device Consultant

EndoPill / Trendlines Medical Singapore
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Epic MD
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Escala Medical
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Fibiosec
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Flight Medical
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Gordian Surgical
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Hairstetics
Consulting engagement in medical device development and R&D.

Medical Device Consultant

InspireMD
Introduced humidity control to address inconsistent coating results for polyurethane coated stents, increasing production yield from 50% to 75%.

Medical Device Consultant

Ivory Graft
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Laminate
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Mavrik Dental
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Maxillent
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Nurami Medical
Consulting engagement in medical device development and R&D.

Medical Device Consultant

O2Cure
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Paragate
Consulting engagement in medical device development and R&D.

Medical Device Consultant

Rapid Medical
Consulting engagement in medical device development and R&D.

Medical Device Consultant

RedDress Medical
Consulting engagement in medical device development and R&D.

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