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Helping medical device manufacturers develop, validate, and commercialize compliant packaging systems with confidence.

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Services

Packaging Development

Package design, material selection, design verification, and development support.

Packaging Validation

Protocol development, execution support, gap assessments, and reporting.

Sterilization Support

ETO, Gamma, and Electron Beam packaging readiness and compatibility support.

Supplier Evaluation

Packaging supplier assessments, technical reviews, and material selection.

Risk Assessments

Packaging FMEAs, transportation evaluations, and design reviews.

Strategic Consulting

Flexible support ranging from short-term projects to embedded engineering.

Founder

Jonathan Eiswerth

Jonathan Eiswerth

Principal Packaging Consultant

Jonathan Eiswerth provides medical device packaging expertise focused on packaging development, validation, sterilization compatibility, commercialization readiness, and regulatory compliance.

His approach combines technical expertise with practical execution to help medical device companies accelerate development while maintaining quality and compliance requirements.

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Selected Experience

Packaging Validation

Protocol development, execution support, report generation, and remediation.

Sterile Barrier Systems

Tyvek pouches, thermoforms, trays, and custom sterile barrier systems.

Sterilization Modalities

ETO, Gamma, and Electron Beam compatibility and readiness support.

Regulatory Standards

ISO 11607, ASTM standards, transportation testing, and compliance support.

Project Examples

Packaging Validation Recovery

Supported remediation activities and accelerated project completion timelines.

Sterilization Readiness Assessment

Evaluated package materials and designs prior to sterilization validation.

Supplier Selection Program

Led technical evaluations and supplier down-selection activities.

Contact Us

Call or email us to discuss your packaging needs.