Own Brand Labelling Medical Devices

OBL - Own Brand Labelling Medical Devices (MDR …

https://easymedicaldevice.com/own-brand-labelling/

Own Brand Labelling or OBL is the action to buy a product that is already finished from another manufacturer and to put your own brand on it. Imagine that I am putting surgical instruments on the market. In my portfolio, I don’t have scissors. Instead …

Device Labeling | FDA - U.S. Food and Drug Administration

https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling

Device Labeling Introduction to Medical Device Labeling Label vs. Labeling The U.S. Food and Drug Administration (FDA) develops and administers …

Private Labeled Devices with FDA Approval - Medical Device …

https://medicaldeviceacademy.com/private-labeled-devices-with-fda-approval/

Own Brand Labelling - the OEM PLM process - seleon GmbH

https://www.seleon.com/en/regulatory-affairs/own-brand-labelling-the-oem-plm-process/

The PLM approves the medical devices in a simplified procedure under its name. The PLM buys the medical devices from the OEM and markets them as its own …

Q & A's: What is Medical OEM? What's Own-Brand Labeling?

https://bmpmedical.com/what-is-a-medical-device-oem/

A medical OEM is an acronym for an Original Equipment Manufacturer that produces medical devices. Medical OEMs are an important part of the medical device …

Private label for Medical devices - Ce Mark Medical

https://www.ce-mark-medical.com/knowledgebase/private-label-medical-devices/

Brand loyalty: Private branding allows you (or your customers) to create your own unique image, which creates a marketing identity and promotes stronger customer recognition …

EU MDR Impact on OBL & PBL Private …

https://www.orielstat.com/blog/obl-pbl-private-label-medical-devices-eu-mdr/

The EU MDR puts private labeling on life support. With the publication of the EU Medical Device Regulation (MDR) in 2017, the EU reinforced earlier guidance published by the MHRA. While …

Conformity Assessment of Own Brand Labelling - Team NB

http://www.team-nb.org/wp-content/uploads/2015/05/nbmeddocuments/Recommendation-NB-MED-2_5_5-Rec_5_Conformity_Assessment_of_Own_Brand_Labelling.pdf

Description of “Own Brand Labelling” manufacturer “Own brand labelling” manufacturer means the person or company re-labelling a device with existing CE Marking from a …

Private label process for FDA - Medical Devices Group

https://www.medicaldevicesgroup.net/medical-devices/private-label-process-for-fda/

A company is interested in getting a private label agreement with an OEM to sell a Class II medical device in the USA. The OEM has 510 (k) clearance and the only product …

How to Create a Label as per EU MDR 2017/745?

https://easymedicaldevice.com/create-a-label-eu-mdr-2017-745/

Medical Device Labeling Requirements as per EU MDR: If there is no expiration date, manufacturers should include the device’s name and trade name, as …