APPROVAL / CERTIFICATION
Getting Regulatory Approval
Several industries require approval by the regulatory authority prior to use of the product. Real Time believes that approval/certification support is critical to our clients success. We have supported our clients at both project start & project end with approval activities.
Specific industries require a plan to be presented to the authorities at the project start on regarding how the project will be developed. A series of Stage Of Involvement audits may be required during the project's development with the culmination of proof that the product works as advertised. Real Timesupports all of these activities.
Specific industries require a plan to be presented to the authorities at the project start on regarding how the project will be developed. A series of Stage Of Involvement audits may be required during the project's development with the culmination of proof that the product works as advertised. Real Timesupports all of these activities.
WHAT WE OFFER
Regulatory Support
Certification support is performed throughout the entire project life cycle with a majority of support at the beginning and end of the project. When done correctly, the project runs smoother, as expected, and without delays or extra cost at the end.
Providing Embedded Regulatory Skills Since 1997

PROJECT
START
Process Development Document Creation
____
Certification Authority Meeting
____
Checklist Creation

THROUGHOUT
PROJECT
Reviews
____
Audits
____
Quality Control
____
Configuration Control
____
Issue Tracking
____
Client Meetings
____
Regulatory and/or Certification Authority Meetings

PROJECT
END
Code Coverage Reviews
____
Test Procedure Reviews
____
Test Results Reviews
____
Development Artifact Reviews
____
Issues Log Reviews
____
Failure Analysis Reviews
