Medical device process validation

Confidence and results

medical device product development process
Along with a commitment to absolute quality standards, we offer rigorous process validation, so you can be confident your medical devices and components are defensibly accurate. We are:
  • FDA registered as a contract manufacturer
  • 21 CFR 820 compliant
  • ISO 9001 and ISO 13485 certified
  • Proficient in Class I, II and III devices

We use empirical data backed with sound statistical analysis to understand and control all sources of variation that can affect product quality. This enables us to we prove out and provide documented evidence your product will meet specifications and quality attributes. And we provide all the documentation needed for your design and device history files, and device master record.

Our team of specialists includes certified packaging professionals and quality engineers. Among other areas, they’re experienced in medical device process validation methodologies, Geometric Dimensioning and Tolerancing (GD&T) and scientific process development.

Case Study

Unique stabilization solution solves global OEM’s legacy “pain point”

Specializing in medical device process validation for:

  • Cardiac rhythm devices
  • Diagnostic devices
  • Drug delivery systems
  • Neuromodulation devices
  • Ophthalmic devices
  • Orthopedic devices
  • Surgical devices
  • Vascular devices
  • And more!

Our suite of integrated contract manufacturing services, enhanced by our SmartStack® and NeuroStack® technologies, provides a competitive advantage with customizable linear contact systems. Plus, our facility features controlled environments, ISO 7 (class 10,000) cleanrooms and cleanroom production cells with integrated vision systems capable of operating at ISO 5 (class 100) level. *Moldflow® is a registered trademark of Autodesk® Inc.

501 County Road E2 Extension
New Brighton, MN 55112
Phone: +1-651-633-4200
Fax: +1-651-633-5486