PERFECTNEXT SMC
MedTech Contract Manufacturing
Legal Compliance Document

Privacy Policy & Data Governance

GDPR Compliant ISO 13485 Data Controls Effective: January 1, 2026
Scope: This Privacy Policy applies to all B2B clients, RFQ submitters, partners, and visitors interacting with perfectnextsmc.com and our digital channels. By submitting an RFQ or contacting us, you acknowledge reading and agreeing to this policy.
1

Information We Collect

Perfect Next SMC collects only the business information required to evaluate and fulfill B2B contract manufacturing service requests. We do not collect personal consumer data.

Contact & Identity Data

  • Full name and job title
  • Business email address
  • Phone number
  • Company name & country

Technical & Commercial Data

  • Bill of Materials (BOM) specifications
  • Product category & volume data
  • Engineering drawings (shared voluntarily)
  • Purchase order & quotation correspondence
We never collect government ID numbers, financial account details, or personal consumer health data. Our data collection is strictly B2B and purpose-limited.

2

How We Use Your Data

Data collected is used exclusively for the following legitimate business purposes. We operate on a data minimization principle: we only collect and process what is strictly necessary.

RFQ Processing & Engineering Quotations

Evaluating feasibility, costing production runs, and preparing formal manufacturing quotations based on your BOM submission.

Manufacturing Order Fulfillment

Managing production scheduling, quality control documentation, shipping logistics, and delivery confirmation for active contracts.

Client Communication & After-Sales Support

Responding to inquiries, providing shipment tracking updates, and handling post-delivery quality assurance follow-ups.

Your data is never used for unsolicited marketing, third-party advertising, or sold to data brokers. All communications are opt-in B2B professional contact.


3

NDA & Intellectual Property Confidentiality

We understand that your product designs represent proprietary intellectual property and competitive advantage. All assets shared with Perfect Next SMC are treated as Strictly Confidential Trade Secrets from the moment of receipt.

What We Protect Under Confidentiality

CAD files, technical drawings & blueprints
Bill of Materials (BOM) & product specifications
OEM brand identity, logos & packaging designs
Pricing, volume, and commercial terms
Instrument geometry & material compositions
Regulatory submission strategies & DHF content

NDA Process

1

Contact us at info@perfectnextsmc.com and request our standard MedTech Mutual Non-Disclosure Agreement.

2

Alternatively, send your company's own NDA for our legal review and countersignature. We respond within 24 business hours.

3

Once executed, you may share full technical drawings and BOM with confidence through our secure email channel.


4

ISO 13485 Quality Records & Regulatory Traceability

In compliance with ISO 13485:2016 and applicable FDA 21 CFR Part 820 device manufacturing regulations, manufacturing records are maintained in encrypted, access-controlled storage for mandatory audit retention periods.

Record Type Retention Period Access Level
Device History Record (DHR) Lifetime of device + 5 years min Client + Regulatory Only
Certificate of Conformance (CoC/CoA) 10 years minimum Client + Regulatory Only
Bioburden & Sterility Records 10 years minimum Internal QA + Client
Lot Traceability & Serialization Log Device lifetime + 2 years Internal QA + Client
Passivation Test Reports (ASTM A967) 7 years minimum Internal QA

5

Third-Party Services & Sub-Processors

We use a minimal set of trusted third-party services necessary to operate our business. These processors are bound by data processing agreements and comply with applicable privacy regulations.

Web3Forms (Form Submission)

Processes RFQ form data and transmits encrypted notifications to our engineering team. No permanent data storage by Web3Forms beyond transmission routing.

Privacy-Respecting Website Analytics

We use lightweight, cookieless analytics to understand aggregate page performance. No individual visitor tracking, behavioral profiling, or advertising pixels are deployed on this website.

DHL / FedEx / UPS (Logistics Partners)

Shipping recipient details (company name, address, phone) are shared with freight carriers solely for shipment routing and customs clearance. Governed by carrier DPA agreements.


6

Data Retention Policy

We retain business contact and technical data only as long as necessary for the purposes described, or as required by ISO 13485, FDA, and international trade regulations. Upon client request, non-regulated data can be deleted within 30 days.

2 Yrs
Prospect / RFQ Contacts
Retained for follow-up unless opted out earlier.
10 Yrs
Active Client Records
QA documentation, batch records, commercial contracts.
Lifetime
Regulatory DHR Records
Mandatory device history per ISO 13485 / FDA.

7

Your Rights Under GDPR & Global Privacy Laws

If you are located in the EU/EEA, UK, or other jurisdictions with data subject rights, you hold the following rights regarding your personal data held by Perfect Next SMC:

Right of Access

Request a copy of all personal data we hold about you.

Right to Rectification

Correct any inaccurate or incomplete data we hold.

Right to Erasure ("Right to be Forgotten")

Request deletion of non-regulatory data. Note: ISO 13485 DHR records are legally mandated and cannot be erased.

Right to Data Portability

Receive your data in a structured, machine-readable format.

Right to Object

Object to processing of your data for direct marketing or profiling purposes.

Right to Restrict Processing

Request that we limit how we use your data while a dispute is being resolved.

To exercise any right, contact our Privacy Officer. We will respond within 30 calendar days.


8

Contact Our Privacy & Compliance Officer

For all data privacy inquiries, GDPR requests, NDA negotiations, or regulatory compliance questions, contact our dedicated legal and compliance desk:

Perfect Next SMC Legal Desk

SMC Manufacturing Complex, Sector 4, Sialkot Export Zone, PKT
Available 24/7 (Contact Any Time)

Response SLAs

General Privacy Inquiry5 Business Days
GDPR Data Subject Request30 Calendar Days
NDA Review & Countersign24–48 Business Hours
Data Breach Notification72 Hours (GDPR Art. 33)