Every inquiry begins with a mutual non-disclosure agreement. Tell us about your device and we respond with a tailored manufacturing proposal within 24 hours.
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Answers to questions we receive regularly from medical device companies considering an EMS partner.
Yes. As a medical device contract manufacturer, we handle proprietary designs, BOMs, and regulatory strategies. Our mutual NDA is standard and protects both parties. We use DocuSign for fast execution.
It depends on the product complexity and scope. Prototype/NPI runs start from 5-10 units. For volume production, typical MOQs range from 50-500 units depending on BOM cost and setup requirements.
Yes. We provide the full manufacturing documentation package: DMR, DHR, process validation records (IQ/OQ/PQ), material certifications, and traceability reports formatted for your regulatory submission.
We are primarily a manufacturing partner, but our NPI team provides DFM (Design for Manufacturability) review, component engineering (alternate sourcing, lifecycle analysis), and test development services.
NPI/prototype: 2-4 weeks. Volume production: 6-10 weeks depending on BOM lead times and complexity. We maintain strategic buffer stock for long-lead-time components on repeat orders.
We run quarterly BOM scrubs against manufacturer EOL/PCN databases. For medical programs, we proactively identify at-risk components and propose form-fit-function alternates or last-time-buy strategies.