Scarlet Pros
1. Modern Communication: Young, tech-savvy team uses tools like shared Slack channel for communication.
2. Innovative Submission Process: Uses GitHub and markdown files instead of traditional PDF/Excel documents.
3. Structured Guidance: Atomic forms provide clear expectations and reduce ambiguity.
4. Remote Audits: Less time-consuming than traditional on-site audits.
5. Responsive to Feedback: Implements improvements in a reasonable timeframe.
6. Customer-Centric Approach: More focused on customer needs compared to traditional notified bodies.
Scarlet Cons
1. High Learning Curve: Requires proficiency in GitHub and markdown, challenging for non-technical staff.
2. Lack of Overview: Splitting documents into multiple files makes it difficult to maintain a holistic view.
3. Unclear Process Structure: Unexpected additional checks and steps not communicated in advance.
4. Expensive Subscription Model: Potentially high long-term costs, especially for startups.
5. Rigid Software: Limited flexibility for customization or adding rationale for decisions.
6. QMS Limitations: Not a complete QMS solution, requiring additional tools and manual work.
7. Data Export Challenges: Difficulty in converting data back to traditional document formats.
Performance
- Initially slower than expected, but likely to improve over time.
- Strong and capable team overall.
Best Suited For
- Startups with small, tech-savvy teams (including regulatory/clinical affairs).
- Companies planning multiple medical software devices with frequent significant changes.
Not Recommended For
- Teams lacking technical expertise (especially in Git/GitHub).
- Single medical device projects with infrequent significant changes.
Additional Notes
- Venture capital-driven, which may influence priorities.
- Subscription model can be expensive long-term (rumored up to €12k/month for some startups).
- Remote audits are a significant advantage.
- Requires maintaining separate QMS with SOPs and evidence collection.
(Editorial note: Scarlet charges a monthly fee, in this case 5k€ / month. As our price field only displays numbers, we entered an exemplary cost over 2 years which is 5k€ * 24 months = 120k€.)