Frequently Asked Questions

What is the typical sample kit turnaround?

Sample surgical trays and prototype laser-marked instruments are processed and dispatched within 5-7 business days via express air courier with full tracking.

Do you support DDP (Delivered Duty Paid) shipping?

Yes. We manage all international customs clearance, duty payment, and logistics under DDP terms directly to your US, European, Middle Eastern, or Asian distribution facility.

Can you sign our NDA before BOM submission?

Absolutely. Request our standard MedTech NDA or email your legal document to [email protected] before sharing any proprietary drawings.

What is your minimum order quantity (MOQ)?

We accommodate initial sample evaluation kits starting from just 10 units up to 500 pilot units for quality & design validation. High-volume enterprise pricing applies to 2,500+ units per SKU.

Are your instruments made from medical-grade steel?

Yes. All our instruments and components are manufactured using verified medical-grade stainless steel (such as 316L or 420 J2, depending on the application) strictly adhering to international biocompatibility standards.

Can you handle custom branding and white-labeling?

Yes, we specialize in OEM white-labeling. We offer precision laser marking for your brand logo, part numbers, and tracking codes directly on the instruments and customized Tyvek sterile barrier packaging.

How do testing quantities and prototype samples work?

If you request a low testing quantity (like 1 to 10 units), our process generally follows these rules:

• Paid Prototypes Small testing runs are rarely free. You will generally be charged an upfront prototyping or engineering fee to cover machine setup and laser-marking calibration.
• Component-Level Evaluation For standard surgical or dental hand tools, getting a small testing batch is relatively easy. However, if your kit requires a custom plastic thermoformed tray, you will have to pay for the initial mold tooling before we can stamp out your test units.
• Cleanroom Validation Bypass To test the physical tools, we will often send you unsterilized, non-cleanroom samples first. Full sterile-barrier tray sealing inside our ISO Class 7 Cleanroom is usually reserved for the final production verification run, as running those machines for a handful of units is highly inefficient.

What information is required for sample approval?

According to the Perfect Next SMC Manufacturing Guidelines, our engineering team will evaluate your request within 12 hours. To get a testing batch approved, you must supply us with:

• Technical Specifications A clear Bill of Materials (BOM) or detailed engineering drawings of the requested instruments/kits.
• Commercial Forecast The target commercial order volume and expected timeline for mass production.