Commitment To Quality

Doctor with patient. Quality Saves Lives.

At Vention, we understand that we’re not just manufacturing products—we’re creating a component or finished device that will be used to save or enhance a patient's life. That’s why we’re committed to achieving the highest standards of quality in everything we do.

Quality is our #1 priority because lives depend on us. We design and manufacture components and finished devices that have a direct and positive impact on the lives of countless patients around the world. From our line workers to our design engineers, we hold ourselves to the highest standards of quality. At Vention, our quality mantra is: Think Quality. Be Quality. Go Beyond.

Regulatory and Compliance

With 35+ years of medical device experience, we have developed a thorough understanding of the complex regulatory environment. Every product is manufactured to exact specification, in full compliance with FDA guidelines, at one of our ISO-certified facilities.

Certifications and registrations:

  • ISO 13485:2003 Certified
  • FDA Registered and compliant with the Quality System Regulation
  • ISO 14971:2007 Risk Management Certified
  • EN ISO 14971:2012 Risk Management Certified
  • Class I, II, and III devices, including Premarket Approval (PMA) products
  • ISO 7 and ISO 8 Certified Cleanroom Controlled Environments
Medical device quality and compliance through automation

Compliance through Automation

One of the ways we ensure the highest level of quality and compliance in manufacturing is by implementing proven automated processes and systems, including:

  • MasterControl: Electronic quality management system
  • Predisys: Statistical Process Control (SPC) software
  • PlantStar: Production and process monitoring system
  • Optical Gaging Products® (OGP): Precision, optical, measurement system
Dedicated on-site teams ensure compliance with rigorous internal quality systems

Global Quality Systems

Our enterprise-wide quality policy and program are designed to ensure consistent high quality and compliance at every location, on every project, at every stage of the product lifecycle. Dedicated on-site teams ensure compliance with rigorous internal quality systems, some of which include:

  • Supplier management
  • Internal audit processes
  • Validation strategy
  • Design controls
  • DHF-ready documentation

Download our location-specific registrations and ISO certifications

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