Medical devices

Medical devices

    Medical device labeling is an important document provided by the manufacturer about device use, risks, and all necessary data. It helps medical practitioners for its safe use while completing all the regulatory compliance.

    The product labeling, package insert, and artwork are done based on EUMDR, USFDA, and CDSCO Medical Device Rule 2017.

    Content of Labelling

  • Product name, model, and size.
  • The name of the applicant, registered address, manufacturing address, contact information, and after-sales service organization.
  • The registration number or record number of the Medical Device.
  • The preparation or revision date and version information of the Instructions for Use.
  • The structures and composition.
  • The performance indicators.
  • A brief description of the operational principle or functional mechanism.
  • The intended use.
  • Description of installation, test, and usage.

    Supported documents from the Client

  • All information regarding the product including name, chemical composition, manufacturing date, expiry date, license no., description of the product, nature of selling for the particular product, and proper purpose of the service taken from us.
  • Storage conditions.
  • Name of the applicant, registered address, manufacturing address, contact information, and marketing authorization holder.
  • Other contents that shall be included additionally.
  • Product specimen in case of artwork (if exact size not available in mm).