Labeling Services for Medical Device
- SPL submissions
- UDI listings
- eIFUs (Electronic Instruction for Use)
Many Health Authorities have established and are in the process of establishing process to enable Medical Device developers submit relevant regulatory information in electronic format.
For the purpose of this health authorities have provided standards that needs to be followed for submission of such information.
Having the experience of preparing, validating and submitting numerous documents in the electronic format, Makrocare can help companies comply with and reduce time and cost of such submissions.
MakroCare offers complete support related to UDI compliance. Helping by guiding on establishing internal processes, collecting relevant data,staging information in structured formats as well as managing all relevant submissions.
MakroCare also helps in Standards consulting specific to UDI. Know more about UDI
eIFUs (Electronic Instruction for Use)
eIFU are in some case required as per compliance good practice as well as it is efficient in today’s ear of web technology and information access.
As an example, providing access to product related information easily and efficiently in comprehensible format can help a surgeon review a important information about a product during a critical process.
MakroCare helps Medical Device companies develop IFUs in Electronic format and maintain them online, to be accessed by end-users.