Medical device product labelling regulations are evolving constantly to provide more transparent information on patient safety, risks, warnings, symbols and precautions.label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device.
As results of new MDR and IVDR regulations, each Manufacturer shall maintain and publish the eIFU on company websites and in applicable regional languages. The medical device labeling includes any type of packaging or device identification, as well as anything that describes the device, its capabilities, and its intended use.
Techsol offers end-to-end medical device labeling services that span across updating, reviewing, analyzing, tracking, and maintaining medical device labeling changes.
- Label compliance
- Life cycle management (post approval services/changes)
- Local regulatory requirements alignment
- Create, update & review contraindications, warnings, precautions
- Create, update & review Instructions for Use (IFUs), patient information / patient guides, treatment guides, user manuals, maintenance manuals and other types of labeling components
- Quality check of submission and commercial artworks
- Gap analysis between distributed labels & submitted labels
- Tracking global medical device and EU MDR labeling requirements and changes
- Investigational Device Labeling Requirements
- Unique Device Identification
- Symbols in Labeling
- Symbology management