General
Why does Scarlet require external consultants to sign a separate NDA?
Why does Scarlet require external consultants to sign a separate NDA?
External consultants are indirectly covered by the existing confidentiality protections that Scarlet has in place with our customers. Here is why we require them to sign a direct NDA with Scarlet:
Broad access to Scarlet’s product: We don't distinguish between access levels for our customers and their third party consultants. Consultants are therefore granted extensive access to Scarlet’s product, which includes a significant portion of our intellectual property (IP).
Parallel missions: While our customers’ internal teams are focused on building a device and bringing it to market, external consultants may work with multiple manufacturers and multiple notified bodies. Interests in relation to the use of Scarlet’s IP could therefore vary.
Urgency in managing breaches: Addressing breaches swiftly is critical. Having a direct NDA allows us to address any issues immediately with the relevant consultant rather than relying on a customer to take action.
While we fully recognise that the vast majority of external consultants pose no risk to Scarlet’s confidential information and acknowledge that signing an additional NDA offers limited extra legal protection, we believe it serves as an important reminder to third party consultants about the sensitivity of Scarlet's IP. It also ensures consistency in messaging received by consultants who are engaged by different customers.
The NDA process is typically quick and straightforward.
Can I make changes after I submit my application?
Can I make changes after I submit my application?
We do not recommend making changes to your data when undergoing assessment. If you have made significant changes after submitting your application, we ask that you inform us before updating the data in your repository. You will then tag a new release and resubmit the application to Scarlet.
Can I make changes after I have been certified by Scarlet?
Can I make changes after I have been certified by Scarlet?
You may. But you'll need to notify us of changes to your QMS, and to your device(s), in accordance with MDR. We may need to approve those changes before you can ship them, so please give us as much notice as possible.
Nonconformities
How many opportunities are there to resolve a nonconformity
How many opportunities are there to resolve a nonconformity
You will have two opportunities to resolve a nonconformity:
Initial review: Identification of finding.
Second review: Assessment of response, e.g. planned or completed corrective actions.
Third review: If the response is deemed unacceptable, a review of improved corrective actions will be conducted.
What happens if my response to a nonconformity is deemed unacceptable after the third review?
What happens if my response to a nonconformity is deemed unacceptable after the third review?
If your response is still deemed unacceptable after the third review, we may decide to terminate the current conformity assessment and require a re-audit. We hope to avoid this outcome, by focusing on high-quality data and feedback to ensure efficient assessments.
Why is there a limit on the number of feedback rounds?
Why is there a limit on the number of feedback rounds?
The regulations require us to rigorously protect our impartiality. Our status as a notified body is dependent on it. Unlimited rounds of feedback could result in:
over-familiarity with your data, to the extent that we are no longer critically assessing the facts presented,
criticisms of "coaching" you toward corrections, that we are then required to (but cannot) impartially assess.
The total number of feedback rounds is at the discretion of our assessors. It may vary depending on assessment complexity and circumstances."
Does Scarlet have any specific requirements for our internal audits?
Does Scarlet have any specific requirements for our internal audits?
No, other than the requirements outlined in ISO 13485 (and by extension ISO 19011), Scarlet does not impose additional requirements on your internal audits.
Product Characterisation
How does Scarlet utilise the output of PC in assessments?
How does Scarlet utilise the output of PC in assessments?
The PC output provides a framework for Scarlet's assessors to understand the product and its intended use.
The information gathered during PC forms the foundation for many aspects of the technical documentation required for certification (e.g. software, clinical, risk), helping streamline the later stages of the process.
PC leads manufacturers through a classification process for their device(s) and accessories, which sets expectations for the scope and depth of assessment Scarlet has to do during the certification process.
As such, the overall goal is to enable you to have a much more streamlined downstream assessment process
What is the difference between Pre-application and Product Characterisation?
What is the difference between Pre-application and Product Characterisation?
Pre-application serves as a rough sketch to establish the scope of your certification and product understanding. Product Characterisation builds upon this by acting as a detailed blueprint with greater emphasis on technical and regulatory specifics.
Why does some information requested during Product Characterisation overlap with Pre-application?
Why does some information requested during Product Characterisation overlap with Pre-application?
The overlap is intentional. While Pre-application focuses on an initial understanding of your product, Product Characterisation allows you to refine and expand upon your responses with more technical detail. This iterative process ensures a more thorough evaluation and avoids missing critical details.
Can I update my initial responses from Pre-application during Product Characterisation?
Can I update my initial responses from Pre-application during Product Characterisation?
Yes, Product Characterisation provides an opportunity to adjust and enhance your initial responses based on insights gained during the Pre-Application phase and further understanding of Scarlet’s regulatory framework.
How long does Product Characterisation take?
How long does Product Characterisation take?
This can be a 3-5 week process, depending on how engaged your team is.
Can we access all PC specs at once, rather than receiving them sequentially across three parts?
Can we access all PC specs at once, rather than receiving them sequentially across three parts?
No, the specs are provided sequentially. Each part builds on the previous one, so accessing all specs upfront would bypass the intended progression.
Can we access the full technical repository for conformers before completing PC?
Can we access the full technical repository for conformers before completing PC?
No, unlocking the technical repository before completing PC would trigger downstream errors, making it difficult to submit an error-free repository after each part of PC. This is because PC specs link to other technical specs, and the scope is intentionally limited at this stage.
However, we can provide a preview of the technical specs that will be unlocked after PC. If you’re interested in a preview, please reach out to the support team via Messenger.
Quality Audits
How long does it take for Scarlet to review and approve my quality application?
How long does it take for Scarlet to review and approve my quality application?
Review times may vary depending on the complexity of your QMS processes and the completeness of your submission.
How do I track the status of my application once it’s submitted?
How do I track the status of my application once it’s submitted?
Scarlet provides weekly status updates via email after submission.
What happens if I don’t resolve all the problems in the Completeness Check?
What happens if I don’t resolve all the problems in the Completeness Check?
All problems must be resolved before your application can be submitted. If any problems remain unresolved, Scarlet will flag these during the Application review process, which may delay the assessment.
How long before the Surveillance audit should I submit their application to Scarlet?
How long before the Surveillance audit should I submit their application to Scarlet?
The manufacturer must submit their QMS documentation after receiving the Audit Plan and at least one day before the audit begins. The audit plan will be provided no later than two weeks before the scheduled surveillance audit. This creates a submission window of 1 to 14 days before the audit.
Risk
What is the difference between known and foreseeable hazards?
What is the difference between known and foreseeable hazards?
The concept of known and foreseeable hazards is mentioned throughout: ISO 14971 and IEC 62366
A known hazard is one that has actually occurred with the device in question.
A foreseeable hazard is a hazard that could occur with the device in question.
Supporting Evidence
What is the difference between internal and external supporting evidence?
What is the difference between internal and external supporting evidence?
Internal evidence are things that are generated by themselves, while evidence of external origin is anything from an external party, e.g. training certificates from an external institution, reports from external suppliers, publications etc.
Technical Assessment
Can I move to the next module if I have unresolved findings?
Can I move to the next module if I have unresolved findings?
No, you must resolve all findings from one module before proceeding to the next module in the technical assessment.
For whom does Personnel information need to be completed?
For whom does Personnel information need to be completed?
From the technical assessment perspective, this will depend on whether personnel, either internal or external, have been involved in the clinical evaluation, risk management, usability engineering, software development of their medical device.