The Medical Device
Integrator + Manufacturer

Your partner and navigator for faster, smarter medical device development.

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With experts in engineering, quality, regulatory affairs, and business development, we have participated in the development of a wide variety of products spanning interventional radiology, cardiac surgery, neuro-surgery, gynecological, gastrointestinal, acute care, and general surgery.

ZIEN brings together every element needed to accelerate your product launch, from development and manufacturing to packaging, sterilization, and regulatory compliance.

Our integrated team and infrastructure give startups instant access to the expertise and systems required to bring a device to market quickly, without the high cost of building their own facilities or hiring a full team.

ZIEN provides a Faster, Lower-Cost Path to Market with up to 70% lower development costs and 12-24 months reduction in time to market. We help you streamline the typical development and regulatory timeline so you can focus on commercial success.

ZIEN brings together every element needed to accelerate your product launch, from development and manufacturing to packaging, sterilization, and regulatory compliance.

More about ZIEN Medical

Rapid Product Launch to a Global Market

Smaller companies often face a disadvantage when seeking regulatory clearance, as developing a product while maintaining ISO 13485 certification and FDA 21 CFR compliance can be overwhelming. By acting as the manufacturer of record, ZIEN helps startups and entrepreneurs streamline the product development and regulatory process, getting products to market faster and worldwide.

ZIEN brings together every element needed to accelerate your product launch, from development and manufacturing to packaging, sterilization, and regulatory compliance.

Global Regulatory Compliance