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Quality Management

Quality Management.

Collaborating to develop quality healthcare solutions that improve lives around the globe. Bringing value to healthcare by taking initiative guided by principle.

Value

Creating safe, effective, regulatory-guided healthcare solutions.

Initiative

Committed to collaborative, data-driven and continuous improvement.

Principle

Patient-focused, quality-first global culture.
Where We Operate

Site Registrations.

ISO 13485 certified manufacturing across North America, Central America, and Asia. Download a site-specific certificate from any row below.

Business Entity
Notified Body ISO 13485 Cert
FDA Registration
Nextern Inc.
Nextern Innovation, LLC
BSI — Design, Development, Contract Manufacturing, Testing, Sterilization and Warehousing of integrated systems (electro-mechanical), pneumatic and pulse generating medical equipment, and therapy delivery hand steerable body insertion devices.
FDA Registered
Download Cert
Nextern Costa Rica, Ltd
BSI — Contract manufacturing, warehousing, testing, and sterile and non-sterile barrier packaging of integrated systems, active pneumatic devices, mechanical hand steerable body insertion medical devices, and active pulse generating medical devices.
FDA Registered
Download Cert
Nextern Vietnam, LLC
BSI — Contract manufacturing of integrated electromechanical systems, pneumatic pressure systems, and therapy medical components for bodily fluid treatments. Contract manufacturing of electronic medical devices for skin examination.
FDA Registered
Download Cert
Nextern Shenzhen Trading
Strategic sourcing and supplier quality services across the Asia-Pacific supply chain.
N/A
No download
Nextern Precision Components
dba NPX Medical
Amtivo — Contract Manufacturer Specializing in the Laser Cutting, Heat Treatment, and Post Processing of Metals for Medical Devices.
N/A
Download Cert
Standards & Policies

Certifications & Policies.

Quality System Standards

  • ISO 13485:2016 — Medical Devices — Quality Management Systems
  • 21 CFR Part 820 — FDA Quality System Regulation (QSR)
  • ISO 14971:2019 — Medical Devices — Application of Risk Management
ISO 13485 — USA ISO 13485 — Costa Rica ISO 13485 — Vietnam ISO 13485 — China ISO 13485 — NPX

Policies

  • Global Responsible Minerals Sourcing Policy
  • Supplier Code of Conduct
  • Privacy & Data Protection
  • Information Security Policy
Minerals Sourcing Supplier Code Privacy Policy