Labeling - Unique Device Identification – UDI

 

FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). The public can search and download information from the GUDID at AccessGUDID.

 

The unique device identification system, which will be phased in over several years, offers a number of benefits that will be more fully realized with the adoption and integration of UDIs into the health care delivery system. UDI implementation will improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.

If you have a question or concern you’d like to share with the UDI team, please contact the FDA UDI Help Desk.

 

Source: http://www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/default.htm

 

Compliance Dates for UDI Requirements

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/CompliancedatesforUDIRequirements/default.htm

 

UDI Resources

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ChangesbetweenUDIProposedandFinalRules/default.htm

 

 

 

Contact me to establish your medical device labeling according to UDI.

Consulting   & Interim Management

Quality Management & Regulatory Affairs  Medical Devices & Combination products

 

Since 1994, effective Strategic & Operative experience in Quality Management & Regulatory Affairs for Medical Devices industry, within the fields of Ophthalmology, Neuro-stimulation, Vascular Intervention, Cardiology, Heart Surgery, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, CT & NMR digital Imaging (3D), and in vitro Diagnostics.

Technical Documentation (DHF, DMR, DHR) including Analysis & Evaluation of Product Function & Safety, Biocompatibility, Packaging, Labeling (UDI), Sterilization, Laboratory results, Software & Hardware.

Compliance to applicable Standards (ISO, IEC, EN, MIL).

Manufacturing Process Verification, Validation (IQ, OQ, PQ).

Product & Production-process Risk Management (Risk Analysis & Risk Control), including Additive Manufacturing. 

Clinical Evaluation, Organization of global multicenter Clinical Studies.

Audits of Production Processes & Suppliers.

Medical Device Reporting to Competent Authorities (e.g. BfArM, FDA).

Corrective And Preventive Action (CAPA) / Non-Conformity (NC) / corrective Project.

On site Support in Notified Body audits, and FDA inspections.

Effective management leading to a multitude of marketing approvals in the EU, Americas (FDA), & Asia, including Reimbursement schemes.

 

 

Dr. Hekmat CONSULTING

www.hekmat-consulting.de

 

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Im Brühl 10/1, 72144 Dusslingen, Germany  (Stuttgart area)

Email: anusch.hekmat@gmail.com

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