Is Greyack Medical FDA registered and ISO 13485 certified?

Yes. Our medical manufacturing operations are FDA registered and certified to ISO 13485, the international quality management standard for medical devices. Certificates are available to qualified OEM buyers during supplier qualification.

Which medical device markets do you support?

We manufacture components and finished devices for orthopedics, spine, dental, surgical robotics and life sciences, and we apply the same disciplined processes to aerospace contract manufacturing.

Can you take a project from prototype to production?

Yes. Our engineering team provides design-for-manufacturability input, builds prototypes, supports process validation and transitions programs into repeatable production, finishing, assembly and packaging.

What documentation do you supply with medical components?

Typical deliverables include material certifications, inspection reports, first article inspection data and lot traceability records to support your design history file and regulatory submissions.

How do international OEMs start a project with Greyack Medical?

Send drawings or 3D models, material requirements, target volumes and applicable standards to info@greyackmedical.com. An engineer reviews manufacturability and responds with recommendations and next steps.

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