End-to-end ster­ile pack­ag­ing from a sin­gle US-based partner

We man­age your entire pack­ag­ing process, from mate­r­i­al selec­tion to ster­il­iza­tion-ready prod­uct. Our Exton facil­i­ty runs on Swiss-engi­neered process­es with full doc­u­men­ta­tion, scal­able capac­i­ty, and built-in qual­i­ty assurance.

ISO Class 7 cleanroom ISO 13485 certified ✓ Full process documentation
✓ FDA-aligned processes ✓ Scal­able capacity ✓ Swiss-engi­neered quality

Proven Medtech Project Examples

Process Transfer

A line moved from CH to the US in 8 months

Transferred, validated and released to production on schedule.

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Portfolio onboarding

A trauma portfolio brought into US production

Onboarded step by step, across manufacturers, local for local.

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FDA SUBMISSION

A Class 3 implant, submission-ready

Text: Packaging and validation built to hold up in FDA review, first time.

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Validation

A double pouch validated to ISO 11607

A finding led to a material change and a second validation, resulting in a more robust sterile barrier.

Packaging Materials

Mate­ri­als engi­neered for ster­ile appli­ca­tions.
Designed for med­ical device and phar­ma­ceu­ti­cal pack­ag­ing requirements.

Quality & Compliance Services

Built-in exper­tise for every reg­u­la­to­ry require­ment
From ster­il­iza­tion val­i­da­tion to accred­it­ed lab­o­ra­to­ry ser­vices. We sup­port your com­pli­ance through­out the entire pack­ag­ing process.

Fruh_Employee Miki Velickovski

Miki Velickovski
Sr. Director Sales & Marketing
+1 267 499 32 47

Ready to find the right packaging solution? Tell us about your project and we'll help you figure out the best fit.