Full-Service Capabilities

Quality & Regulatory Support

Whether you’re developing a Class I, Class II, Class IIb, or Class III medical device, we can work with you to optimize your product for manufacturability, reliability, safety, regulatory compliance, and competitiveness.

An SPG extrusion expert manufacturing catheter extrusions in a clean work area

Enterprise QMS

Our Enterprise Quality Management System provides the tools, systems, and procedures to ensure that we deliver unparalleled manufacturing results and customer satisfaction consistently at our 19 manufacturing sites across 6 countries.

Certifications and Registrations

ISO Certifications

  • ISO 9001:2015
  • ISO 13485:2016
  • AS9100 Certified

View our ISO Certifications

FDA Registered

  • QSR 21 CFR Part 820

ITAR and AECA Compliant

Regulatory Support

An SPG extrusion expert performing quality tests

We can manage the complete approval process for your Class II, Class IIb, or Class III medical device program. Our dedicated team is well-versed in the requirements of regulatory bodies worldwide.

Services include:

  • Regulatory affairs & quality assurance
  • Regulatory & clinical strategy development
  • Design history files/technical files
  • Data management
  • 510(k) and PMA regulatory submission services
  • CE Mark submissions & audit support
  • Approval process management
  • Post approval services – field management

Lean Manufacturing

Quality support by an SPG extrusion expert

Lean Manufacturing is a strategic initiative to help our company to work smarter, to be more efficient, and to eliminate defects. From the factory floor to the leadership team, the Lean culture shapes how we run our business and is incorporated into the entire product lifecycle.

  • Lean principles are established in the design and development phase to eliminate waste and process productivity
  • Manufacturing areas are configured to achieve improvements in productivity, quality, and lead time
  • Metrics are in place to continuously optimize performance

Other Quality Services

In-House Metrology Lab

  • Coordinate measuring machine (CMM)
  • Advanced product quality planning (APQP)
  • First article inspection (FAI)
  • Statistical process control

Process Improvement Methodologies

  • Six Sigma (multiple Black Belts and Green Belts)
  • Kaizen events
  • Supply chain optimization
  • Value stream mapping (VSM)
  • Kanban
  • 5S
Contact a Quality & Regulatory Support Specialist
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