We work with you throughout your application and submission to ensure that we can provide the an efficient and predictable process.
The submission process
We've split the application process into discrete steps to ensure a smooth journey to submission.
Pre-application: We align on the scope of certification to ensure we understand your product and certification needs. This includes the questionnaire you have completed and the clarification call that follows.
Signing pack: You officially sign on as a Scarlet customer, and we start our partnership.
Product Characterisation: You provide detailed information about your product, its features, and its regulatory aspects.
Application creation: You complete all the required workflows to prepare your application.
Application submission: You submit your data for assessment, and we review it for completion and compliance.
What happens after submission?
Once you submit your application, Scarlet will review it for completeness and any unaddressed issues.
We will notify you via GitHub comments whether or not your application has been accepted. If everything is in order, we’ll move forward with the assessment process, which is conducted in two parallel workstreams: Quality and Technical.
The assessment process
Quality assessment
The Quality assessment focuses on auditing your management system. This happens in two stages:
Stage 1 audit
In this stage, we assess whether your management system is ready for the more detailed Stage 2 audit. It’s about ensuring the basics are in place and setting the stage for success
Stage 2 audit
Here, we take a closer look at how well your management system is implemented and its effectiveness. It’s a thorough examination to ensure everything is working as it should.
Any of the four types of findings might be raised during the audits. You will respond by completing the appropriate workflows.
Technical assessment
The technical assessment consists of four sequential modules.
During each of the modules, the findings will be raised as Queries. The queries should only require minor tweaks/clarifications. If a query is unresolved after 2 weeks or requires significant change, it will be turned into a nonconformity.
You must resolve all the findings for a module before we can progress to the next module.
Module 1: Foundations
We’ll look at foundational concepts such as personnel qualifications, requirements, and process plans. This ensures the basic building blocks are solid.
Module 2: Preparations
This stage assesses requirements related to the preparation for device evaluation (including clinical and usability)
Module 3: Generations
Here, we focus on the requirements related to the data generated from evaluation activities.
Module 4: Validations and post-market
In the final module, we assess requirements related to summaries and conclusions drawn from identified and generated data.
We will also assess the preparation for the availability of the device on the market.
Scarlet checks for any residual queries from the previous module before raising queries for the next module.
Throughout the pre-application, submission and assessment processes, you can reach out to our team to ask any questions you have.