Medical Devices Quality Control

Medical Device Image

Engineered Vision has broadened its reach into the medical field with our Medical Device Quality Control & Process Validation through Automated Visual Inspection. The system works by taking a photo of the product on your equipment and is able to inspect hundreds of parts per minute to six sigma repeatability. Validating medical devices has never been so easy and reliable than through the use of Vision with New Deep Learning Techniques where 100% of your parts are inspected. Use this Automated Visual Inspection System for:

  • Medical Devices Dimensional Inspection

  • Rejecting Out of Spec Parts

  • Injection Molded Part Features

  • Confirming Assembly Part Tolerances

  • Packaging Count and Placement Inspection

  • Checking Medical Tubing

  • Contamination Inspection

  • Color Verification

  • Unique Device Identification (UDI) tracking

  • Print and Text Quality (OCR/OCV)

  • 2D Datamatrix

  • Product Traceability

 
Machine Vision System Image

Design & Installation

We can help create the initial specification requirements for vision inspection through to the complete integration, test and commissioning on your line. We have extensive knowledge of integrating vision systems integration and can simplify your validation through 100% part inspection. When designing a new machine there are various contract strategies and partners available for the total machine build - we stay flexible in order to accommodate your contract strategy and are able to work directly with your machine builder to simplify the process for your team.

Coding Image

Validation Services

Performance Qualification (PQ) in the heavily regulated Medical Device industry is critical. Quality & Validation Engineers alike know that everything must be validated, but there are no FDA approved equipment lists as this is application specific. This puts the sole responsibility or burden of proof back onto the customer who is generally drowning in other validation work. We can help your team by providing Validation Solutions to support your unique situation.

Our validation packages for medical devices follow Good Automated Manufacturing Practice (GAMP5) guidelines as well as assessment of validation requirements for 21 CFR 11/210/211 - helping manufacturers in medical devices comply with Good Manufacturing Practice (GMP).

Our engineers understand the importance of precision and repeatability and only use the highest quality vision equipment with guaranteed repeatability customized to your unique medical device quality control need.


Our Process

  1. Free - Specification & Scope development where we can help provide capabilities as well as options you may not have considered

  2. Free - Lab testing on the provided part samples with a skeleton vision program to ensure machine vision will work for your application

  3. Free - Results provided and a customized solution (skeleton) for your application will be created as a proof of concept. At this point we will know where your machine vision problem sits on the basic to complex spectrum and can generate a proposal for your solution.

  4. Proposal acceptance and full vision program developed with proposed hardware.

  5. Testing completed with proposed hardware on customer finished product quality samples.

  6. Software validation script developed and tested.

  7. Final solution shipped to machine builder, final customer, or integrated by our Vision Integration personnel.

  8. Validation Support as required by customer preference.


What's Included in our Typical Package: 

 

Vision Hardware

  • Camera, lens, & light

  • Camera & light Controller

  • Human machine interface (HMI)

  • Std. mounting & cabling

Vision Software

  • Vision Algorithms with lifetime license

  • Customized part inspection & measurement

  • Customized communication to PLC

 

Click Here to Learn the Basics: Machine Vision 101