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AUTOMATION AT
ITS BEST!
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Automated Assembly Equipment
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Automated Test Systems
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Medical Device Assembly
Automation
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Machine Vision Systems
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Robotic System Integrators
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Engineering Services
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Product Development
- Process Development
- Engineering
An ISO
9001:2000 Company
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MEDICAL DEVICE ASSEMBLY AUTOMATION
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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.
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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.
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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.
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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 customers’ facilities.
INNOVATIVE understands our medical assembly customers’
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 customers’ User’s Requirements Specification and INNOVATIVE’s
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.
5 Progress Avenue • Tyngsboro, MA 01879 Tel: 978.649.0200 • Fax:
978.649.0220 • Email:
ipesales@ipeinc.com
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