Understanding Master Information

Understanding Master Information

What is Master Information (MSI)?

Master information (MSI) is a collection of the most common "mandatory attributes" used in regulatory documentation across the medical device lifecycle. MSI was carefully designed to combine fields across three categories/dimensions:

  • General Information: This category includes administrative information such as applicant or sponsor details and point of contact that are mandatory and required across many sections and almost all documents
  • Device Information: This category includes fields like device trade name and model number, attributes such as nature of the contact, electrical or software, etc. to identify product category level requirements
  • Regulatory information: This category includes fields like indications for use, contraindications, and warnings, product code and category, device classification to identify device-specific regulatory

Benefits of completing Master Information

Updating Master Information (MSI) is the recommended first step to get started in a project because completing MSI can fast track your progress and complete up to 20% of your regulatory submission. Here is how the Master information benefits you while working on regulatory submissions:
  1. Simplifies your work by identifying and filtering out requirements that are not applicable for your device so you can focus on only those items that are important
  2. Avoids errors due to inconsistency from re-typing information - Get peace of mind knowing your application will never be rejected due to inconsistent references of vital attributes
  3. Saves you time by auto-populating fields that repeat several times during the course of preparing documentation across your product lifecycle - You can complete up to 20% of your regulatory submissions in under 10 minutes
  4. Cascades any changes to the most frequently updated fields consistently across all documents related to the same device saving you a ton of headache later on

For Space and Project owners, completing Master Information can set your submission up for success by:

  1. Helping you elevate the quality of your submissions by having critical information used consistently throughout all documents
  2. Keeping the entire team focussed and organized from the get-go by focussing on requirements that are important.