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