How We Work: Process, Confidentiality and AI Policy
Clear scope, careful handling of your information and a human expert behind every conclusion.
Our process
- Free intro call (30 minutes): your device, markets, timeline and current status.
- Gap analysis: a written assessment against the applicable requirements.
- Roadmap and fixed quote: work packages, timeline and a fixed-scope, fixed-price proposal.
- Delivery and handover: we do the work with your team, train them and hand the system over.
Confidentiality and NDA
We sign a mutual NDA before any document is exchanged. Your information is used only for your engagement and is never reused for other clients.
Data handling and retention
We keep only the documents needed for the engagement. Project files are retained for [ONAYLANACAK] after the engagement ends, then deleted or returned, unless you ask otherwise or the law requires longer retention.
Secure file sharing
Documents are exchanged through a secure, access-controlled shared folder or your own eQMS, not as email attachments. During remote audits we prefer that you share your screen so records stay in your system.
AI use policy
- No client document is uploaded to an AI tool without the client’s written consent.
- Where a client consents, we only use tools whose terms exclude training models on customer data.
- AI may help with drafting or summarizing; every assessment, finding and conclusion is made and signed off by a human expert.
Conflict-of-interest policy
Before each engagement we check for relationships with the client, its competitors or the suppliers involved. If we cannot be independent, for example in a supplier audit where we have worked for the supplier, we decline or disclose and let you decide.
Remote audits
Remote audits follow a pre-agreed agenda and evidence list. We sample records through secure screen sharing, interview staff by video and use live video walkthroughs for areas that need observation. On-site visits in Türkiye and Europe are available when they add value.
What we do not do
- We do not guarantee FDA clearance, CE certification or any other approval.
- We do not act as US Agent, EU Authorized Representative or Saudi Authorized Representative.
- We do not provide legal services.
Let’s map your route to market in 30 minutes
Tell us about your device, target markets and timeline. You’ll leave the call knowing which requirements apply, where your gaps likely are and what to do first.