Compliance & Processes

Every day we work to exceed customer expectations for process, quality and compliance – because lives depend on it.

With three locations and the industry’s leading engineering, tool-making and production specialists, OKAY Industries is recognized for quality manufacturing for medical applications. We offer 190,000 sq. ft., dedicated to process excellence for medical device compliance and will collaborate with you for the lifetime of the project to ensure a high level of quality that results in peace of mind for your customers.

Results-Driven Excellence, Customized For Your Project.

OKAY Industries has developed a strict in-house validation process that maintains quality and consistency for even the most complex orders. We design and build custom solutions based on order requirements, including production automation and assembly technologies, and can ensure medical device compliance for extremely precise and demanding project specifications.

Our precision manufacturing for medical applications is designed for quality – we identify and verify the effectiveness of process critical variables throughout design, production, and assembly, with efforts that include:

  • CAD Drawings – including electrical schematics, when necessary
  • Designed Experiments and Results
  • Safety Documentation
  • Process Definitions – at each step to clearly describe expectations and standards, include inputs and outputs
  • Setup Instructions & Documentation Spare Parts Lists
  • Work Instructions
  • Quality Documentation – product control plans and PFMEA’s
  • Preventative Maintenance
  • Spare Parts Lists

Our customer-focused operations are driven by quality, and with over a century of experience, OKAY is ready to help you improve your outcomes. When manufacturing for medical device applications, projects typically follow a standard process:

Our medical device manufacturing certifications and registrations include:

Part of Something Greater. Checked at Every Step.

With validation at every stage of the production process – including compliance checks for installation, operation and performance requirements – OKAY Industries works to exceed customer expectations. Our manufacturing for medical application processes adhere to the ISO13485:2016 Quality Management System standard. We are standing by and happy to review your project needs and develop a custom solution for your application.

Contact us or schedule an appointment in our NexTech Labs and discover how our customer-focused collaboration will improve outcomes on your next project.