Medical Device Labeling
 
DEVICES

Labeling – “More than a print on the box”

We all know the labeling definition well and that includes any part of written, printed, packaging and graphics matter that accompanying to the product.

Key is to keep this in compliance and updated at all times in all countries as Health Authorities primary concern remains patient access to high quality, safe and effective, and avoiding access to products that are unsafe.

MakroCare’s Global Labeling team provides advisory and implementation services to ensure your compliance maintained at all times, whether it’s local country labels or compliance (EU) 2017/745.

With our global teams consisting of Physicians, regulatory experts, artwork and operations resources, clients can leverage full outsourcing or complimentary tactical project models.

Label activities that we perform

  • Label compliance
  • Artwork design and management
  • SOPs management (create/review/update)
  • Gap analysis for existing labels (deviation management as per MDR)
  • Create and update labels (Inner/outer) as per MDR requirements
  • Data customization from primary to secondary labels
  • UDI requirements
  • Usage of internationally recognized symbols
  • Life cycle management (post approval services/changes)
  • Local regulatory requirements alignment

IFUs (Instructions for use) activities

  • Compliance with new regulations
  • Gap analysis for existing IFUs (deviation management as per MDR requirements)
  • Create and update the IFUs as per MDR requirements
  • SOPs management (create/review/update)
  • Data consistency with updated CER & BER information
  • Necessary information to end user such as indented use, warnings, precautions, storage & limitations, others
  • Life cycle management (post approval services/changes)
  • Safety compliance support/management
  • Literature search/Source data procurement and competitive information

Benefits

  • Labeling Icon Dedicated labeling teams aligned from a therapeutic perspective
  • Labeling Icon Global FTEs to match speed and cost
  • Labeling Icon Allows you to move form fixed-cost to variable cost based on load and activities
  • Labeling Icon Operations and project management support for your projects

Have Questions? Need Info/Quotes?