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UDI Regulations and Requirements
A directive from the United States Food and Drug Administration (FDA) and the European Commission has introduced legislation regarding the Unique Device Identification (UDI) of medical devices and instruments.
From September 2016, all medical class III devices and instruments that require direct part marking (DPM) must also carry a UDI. Class II and Class I devices will require UDI from September 2018 and September 2020 respectively.
This system will allow greater accuracy in reporting and traceability as well as reducing medical errors by allowing health care workers to quickly identify instruments.
Why Laser Marking is an Effective and Suitable Solution
A directive from the United States Food and Drug Administration (FDA) and the European Commission has introduced legislation regarding the Unique Device Identification (UDI) of medical devices and instruments.
From September 2016, all medical class III devices and instruments that require direct part marking (DPM) must also carry a UDI. Class II and Class I devices will require UDI from September 2018 and September 2020 respectively.
This system will allow greater accuracy in reporting and traceability as well as reducing medical errors by allowing health care workers to quickly identify instruments.
Why Laser Marking is an Effective and Suitable Solution
- Permanent mark capable of lasting product life span
- High contrast marking
- Sterilisation resistant
- Hygienic and smooth
- Unaffected by passivation or other surface treatment
How Pryor & TSA can help with UDI
Pryor has a strong background in working with medical device and instrument manufactures and have developed our own laser and traceability solutions tailored towards UDI requirements.
Our expertise in the integration of vision systems is unmatched in the marking industry. This enables us to validate and verify against industry standards, and even produce full reports and images of the process for a complete traceability and data capture solution.
We can offer the following benefits to our medical customers:
Pryor has a strong background in working with medical device and instrument manufactures and have developed our own laser and traceability solutions tailored towards UDI requirements.
Our expertise in the integration of vision systems is unmatched in the marking industry. This enables us to validate and verify against industry standards, and even produce full reports and images of the process for a complete traceability and data capture solution.
We can offer the following benefits to our medical customers:
- Full traceability and serialisation to ensure unique part marking
- Mark Logos, serial numbers, 1D barcodes, 2D data matrix
- Cognex integration for full part mark verification
- Marking and quality inspection become a single operation, reducing critical cycle time
- Customised software for UDI applications
- Possibility to network our machines to your manufacturing execution system (ME)
For further information on UDI Marking CONTACT
We would like to introduce ourselves as manufacturers of all types of surgical instruments and dental instruments in stainless steel.
and all kind .
We are sure that you will like the quality of the samples as well as prices.
We make special offers to our Customers, if you have any requirement
all kind of surgical instruments and dental instruments , we can offer very competitive prices.
Services:
1 :- We will provide samples by Air Post Parcel.
2 :- We will make replacement in case any defective products .
3 :- All our stainless steel will be having rust-free guarantee.
4 :- All our instruments carry workmanship guarantee.
5 :- order will be dispatched within 3 to 4 weeks.
LOGO: Laser printing free of charges.
We request you to please send us your latest requirement list. We
assure you that you will find us most co-operative and best server
for your company.
Thanking you.
CEO
Register Company.
Factory: Kashmir Road, 51310-Sialkot.
Cell: 0092 340 4131531
E-mail: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="264f484049665555524f4855520845494b">[email protected]</a>
Web site: www.sstinst.com