Innovative Products and Equipment, Custom Automation Equipment

custom automation equipment, automated assembly, automated test systems, medical device assembly, machine vision assembly, robotic system integrators

20 Executive Drive • Hudson, NH 03051 • Phone: 603-246-5858 • Email: email

MANUFACTURING CUSTOM AUTOMATION EQUIPMENT FOR OVER 35 YEARS

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AUTOMATION AT ITS BEST!

| Automated Assembly Equipment
| Automated Test Systems
| Medical Device Assembly Automation
| Machine Vision Systems
| Robotic System Integrators
| Engineering Services
    - Product Development
    - Process Development
    - Engineering

An ISO 9001:2008 Company

TUV ISO Certification

 


MEDICAL DEVICE ASSEMBLY AUTOMATION

INNOVATIVE has been designing and building custom automation equipment for the medical device assembly industry since our company was founded. We have built many automated medical device assembly systems over the years in accordance with the GAMP 4 Guide, and we understand the FDA validation requirements to which our medical device assembly automation equipment and pharmaceutical customers must comply.

Medical automated assembly equipment
Medical Device Assembly

Medical Device Assembly Automation Design for Validation:

  • INNOVATIVE designs automation equipment for installation in clean room environments.

  • We custom manufacture all contact tooling utilizing only non-contaminating materials.

  • We design calibration tools and procedures for each online measurement test.

  • Reject stations are designed with sensors to verify out of specification product is properly removed. Rejected product is often marked or purposely damaged to prevent accidental usage.

  • Computer programs are written to insure critical sensors function each cycle of the machine.

  • Computer program structures are written in a format easy to validate.


Medical Device Assembly Automation Validation Documentation:

  • INNOVATIVE has prepared Design Qualification Reports, Installation Qualification protocols and Operational Qualification protocols for our medical device assembly automation customers.

  • We have also participated in the execution of the IQ and OQ protocols at our medical assembly customersí facilities.

  • INNOVATIVE understands our medical assembly customersí needs for a successful Performance Qualification and designs our automation assembly systems with this in mind.

Medical Device Assembly Automation Support Documentation:

  • INNOVATIVE develops a Functional Design Specification from our customersí Userís Requirements Specification and INNOVATIVEís proposal.

  • Every change to the scope of the project is documented with a signed Engineering Change Order.

  • We work with customers on their FEMA to insure the equipment identifies all critical assembly issues.

Medical Device Assembly Automation Data Collection and Storage:

  • INNOVATIVE incorporates all relevant requirements of 21CFR Part 11 in the design of the systems as required for electronic records and signatures.

  • We have designed and built automation equipment to print, apply and read unique barcodes. Device Assembly and test data is collected and stored by product ID in a database with batch number, date and time stamp.

  • Batch records are down loaded to servers and file comparison is used for transfer confirmation.

  • SPC and process tracking used in the design of the controls systems.

INNOVATIVE understands the critical issues of custom Medical Device Assembly Automation and will be sure that nothing is missed along the way. We do this regularly so we know the proper steps required.


Innovative Products and Equipment, Inc.
20 Executive Drive • Hudson, NH 03051 • Phone: 603-246-5858 • Email: email

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Copyright 2014 Innovative Products and Equipment, Inc., Tyngsboro, MA.  All Rights Reserved.