Terms of Service & Manufacturing Supply Agreement
Table of Contents
Quotation, Purchase Orders & Contract Acceptance
All commercial engagements with Perfect Next SMC commence with a formally submitted Request for Quotation (RFQ). Our quotations are valid for 30 calendar days from the date of issue unless otherwise specified in writing.
Quotation Validity
All pricing is subject to raw material price fluctuations. Firm pricing is locked upon receipt of a signed Purchase Order (PO) within the 30-day validity window.
Purchase Order Acceptance
A contract is formed upon Perfect Next SMC issuing a formal Order Acknowledgement (OA) in response to a client Purchase Order. Verbal or email-only commitments do not constitute binding contracts.
Change Orders
Modifications to an active order (engineering changes, volume adjustments, material substitutions) must be submitted in writing. Change Orders may affect pricing, lead time, and delivery schedules.
Quality Standards & Acceptance Criteria
All medical devices, cleanroom packaged surgical kits, and OEM laser-marked products manufactured by Perfect Next SMC comply with agreed purchase orders, approved engineering drawings, and our ISO 13485:2016 quality management system.
| Quality Standard | Scope | Status |
|---|---|---|
| ISO 13485:2016 | Medical Device Quality Management System | Active (Registered) |
| ISO 14644-1 Class 7 | Cleanroom Air Quality & Particle Control | Validated |
| ASTM A967 | Passivation & Corrosion Resistance (Stainless) | Per Shipment |
| ISO 11137 / ISO 11135 | Gamma & ETO Sterilization Validation | Per Protocol |
| FDA UDI Rule (21 CFR 801) | Unique Device Identification Marking | Client Directed |
Pricing, Payment Terms & Invoicing
All prices are quoted in USD (US Dollars) unless otherwise agreed in a written contract. The following standard payment terms apply to all B2B manufacturing orders:
For new clients and first orders, full prepayment (100% deposit) may be required. Payment via Wire Transfer (TT), SWIFT, or Letter of Credit (L/C). Late payments incur a 2% per month interest charge. All bank charges are borne by the client (SHA terms).
Delivery Terms & DDP Global Logistics
Unless otherwise specified in formal contracts, all international shipments are fulfilled under DDP (Delivered Duty Paid) Incoterms 2020, with freight, insurance, customs clearance, and all duty tariffs managed by Perfect Next SMC.
Standard Lead Times by Order Type
*Lead times are indicative and confirmed upon formal Order Acknowledgement. Expedited production available with surcharge.
Warranty & Defect Remedies
Perfect Next SMC warrants that all products manufactured under a confirmed Purchase Order shall conform to the agreed specifications, engineering drawings, and ISO 13485 quality standards. Our standard warranty period is 12 months from the date of confirmed delivery.
Defect Claim Process
Non-conforming items must be reported within 30 days of receipt with photographic evidence and lot references. Claims submitted after 30 days may not qualify for full remedy.
Remedy Options
At our discretion, Perfect Next SMC will provide: (a) Replacement of non-conforming units at no charge, (b) Credit memo applied to next order, or (c) Full refund for critical defects substantiated by independent third-party lab testing.
Warranty Exclusions
Warranty is void for defects caused by: improper storage, unauthorized modifications, incorrect sterilization processes applied by the client, or use outside the documented product specification range.
Intellectual Property & Non-Disclosure
All client-supplied CAD files, drawings, tooling specifications, brand assets, and proprietary formulations remain the exclusive intellectual property of the client. Perfect Next SMC claims no ownership over client IP provided for manufacturing purposes.
Conversely, all manufacturing processes, tooling developed by Perfect Next SMC at its own cost, proprietary cleanroom protocols, and quality systems remain the intellectual property of Perfect Next SMC.
NDA Commitment
Perfect Next SMC operates under strict mutual non-disclosure obligations on all active and past client engagements. Client names, order details, product configurations, and branding are never disclosed to third parties, competitors, or published in case studies without express written consent.
Regulatory Compliance & Client Responsibilities
While Perfect Next SMC ensures manufacturing compliance with ISO 13485, CE Marking prerequisites, and FDA Class I & II device sourcing standards, the client (as the legal medical device manufacturer of record in their jurisdiction) is responsible for:
- Obtaining and maintaining all applicable device marketing authorizations (FDA 510(k), CE MDR, TGA, etc.) in their target market.
- Ensuring labeling, IFU (Instructions for Use), and language compliance with destination market regulations.
- Conducting post-market surveillance (PMS), vigilance reporting, and adverse event notifications as required.
- Verifying that UDI identifiers, expiry dates, and sterilization lot codes are correctly assigned before product commercialization.
Limitation of Liability
To the maximum extent permitted by applicable law, Perfect Next SMC's total liability for any claim arising from a manufacturing order shall not exceed the total value of the specific Purchase Order giving rise to the claim.
Perfect Next SMC shall not be liable for: indirect, consequential, incidental, special, or punitive damages; loss of business profits or revenue; clinical recall costs arising from client-directed specifications; or delays caused by third-party freight carriers under DDP terms once goods depart our facility.
Force Majeure
Neither party shall be liable for delays or failures in performance resulting from circumstances beyond their reasonable control, including but not limited to: acts of God, natural disasters, government-imposed trade sanctions, port closures, pandemic-related supply chain disruptions, or civil unrest.
In the event of a force majeure, the affected party shall notify the other within 5 business days with written documentation. Delivery timelines shall be extended by the duration of the force majeure event. If the event exceeds 90 days, either party may terminate the specific affected Purchase Order with full refund of any prepaid deposits minus materials already committed.
Dispute Resolution & Governing Jurisdiction
The parties agree to attempt good-faith resolution of any commercial dispute within 30 days of written notice before pursuing formal proceedings. If unresolved, disputes shall be settled through binding international commercial arbitration.
Nothing in these terms prevents either party from seeking urgent injunctive relief from a competent court of jurisdiction to prevent irreparable intellectual property harm.