Fixed-price packages

Clear scope, defined deliverables and a fixed price agreed before we start. Not sure which one fits? Book a free call and we’ll tell you honestly.

All markets

Starter Document Review

Best for: Teams who want to test working with us on a small, defined piece of work.

Scope

  • One procedure or process of your choice
  • Review against ISO 13485 and your target market

You receive

  • Findings report with suggested wording
  • 30-min debrief call
Typical duration
1 week
Starting at
[ONAYLANACAK]
Request this package
United States

QMSR Gap Analysis

Best for: Manufacturers selling, or planning to sell, in the US.

Scope

  • ISO 13485 as incorporated by the QMSR
  • Part 820 additions and connected FDA requirements
  • Audit and management review records exposure

You receive

  • QMSR gap report
  • Prioritized action plan
  • Debrief with your team
Typical duration
2–3 weeks
Starting at
[ONAYLANACAK]
Request this package
All markets

Remote Internal Audit

Best for: Manufacturers under ISO 13485, FDA QMSR or EU MDR who need an independent auditor.

Scope

  • Audit plan agreed in advance
  • Remote audit by video and secure screen share
  • Full QMS or selected processes

You receive

  • FDA-presentable audit report
  • Nonconformity log
  • CAPA recommendations
Typical duration
2–4 weeks
Starting at
[ONAYLANACAK]
Request this package
All markets

Annual Audit Program

Best for: Manufacturers who want continuous compliance without a full-time auditor.

Scope

  • Risk-based annual audit schedule
  • All planned internal audits
  • Follow-up of corrective actions

You receive

  • Audit program
  • Audit reports
  • Quarterly status summary for management review
Typical duration
12-month agreement
Starting at
[ONAYLANACAK]
Request this package
United StatesEuropean Union

Supplier Audit (Türkiye / Europe)

Best for: US and EU companies with suppliers in Türkiye or Europe.

Scope

  • On-site audit at the supplier
  • ISO 13485 and your quality agreement
  • Your checklist or ours

You receive

  • Structured audit report in English
  • Findings with risk grading
  • Supplier status recommendation
Typical duration
1–2 audit days + report within 5 business days
Starting at
[ONAYLANACAK]
Request this package
European UnionTürkiye

MDR Transition Support

Best for: Manufacturers selling in the EU who need to complete MDR certification.

Scope

  • Gap analysis against MDR
  • Technical documentation and GSPR
  • Risk management (ISO 14971)
  • Notified body preparation

You receive

  • Transition plan
  • GSPR checklist
  • Technical file structure
  • Pre-submission review
Typical duration
Phased, scoped after gap analysis
Starting at
[ONAYLANACAK]
Request this package
Gulf

Gulf Readiness (SFDA)

Best for: Manufacturers preparing to export to Saudi Arabia and the Gulf.

Scope

  • ISO 13485 readiness check
  • Dossier readiness check
  • Coordination with your licensed authorized representative

You receive

  • Readiness report
  • Document gap list
  • Hand-over pack for your representative
Typical duration
2–3 weeks
Starting at
[ONAYLANACAK]
Request this package

Need something else?

Most projects start with one of these packages. If yours doesn’t fit, we’ll scope it with you.

Book a free call

Limited monthly capacity — we take on a small number of new clients each month.

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.

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