Medical Devices & Pharmaceutical Startups
Practical Regulatory Pathways. Built for Startups. Designed to Scale.
At Fahmy Consulting, we help medical device and pharmaceutical startups navigate complex regulatory and quality requirements without overbuilding, overpaying, or overengineering.
We specialize in translating regulations into clear, actionable systems that regulators accept, investors trust, and teams can actually run.
Who We Support
We work with:
- Medical device startups (Class I–III)
- IVD manufacturers (IVDR-focused SMEs)
- SaMD & AI/ML health technology companies
- Pharma & combination-product startups
- Spin-offs, incubators, and VC-backed MedTech teams
Whether you are pre-clinical, pre-market, or preparing for scale, we meet you where you are.
Our Core Philosophy
- Most startups fail regulatory readiness because they:
- Treat ISO and MDR/IVDR as paperwork exercises
- Engage Notified Bodies too late
- Build bloated systems that slow innovation
We do the opposite.
- Lean, compliant systems
- Evidence-driven documentation
- Early regulatory clarity
- Designed for audits, not theory
Regulatory & Quality Services
- Quality Management Systems (Startup-Focused)
ISO 13485 (lean, startup-appropriate implementation)
Integrated ISO 9001 / ISO 13485 where relevant
Scalable QMS design (startup → growth → acquisition)
Gap assessments & remediation
Outcome: A QMS that supports development instead of blocking it. - MDR & IVDR Readiness (EU Market Access)
We support full alignment with:
EU MDR (2017/745)
EU IVDR (2017/746)
Annex II & III Technical Documentation
Including:
Intended purpose & claims strategy
Device classification & conformity routes
GSPR / performance requirement mapping
Risk management (ISO 14971)
Clinical & performance evaluation strategy
PMS / PMCF / PSUR frameworks
Outcome: Submission-ready documentation — not endless review cycles. - Clinical & Performance Strategy (Not Just Reports)
We help startups design defensible strategies, including:
Clinical Evaluation Plans (CEP)
Clinical Evaluation Reports (CER)
Performance Evaluation Plans (IVDR)
Article 61(10) justification (when applicable)
PMCF & PMS integration from Day One
Outcome: Evidence that withstands Notified Body scrutiny. - Software, SaMD & AI/ML Devices
Specialized support for:
SaMD classification & intended purpose alignment
IEC 62304 software lifecycle compliance
AI/ML transparency & change control
SOUP & cybersecurity considerations
AI/ML-specific MDR documentation expectations
Outcome: Faster, cleaner reviews for digital health products. - Startup Regulatory Strategy & Early Engagement
We guide startups through:
Pre-submission readiness reviews
Regulatory pathway decisions
Documentation structuring for reviewer efficiency
Preparation for Notified Body interactions
Transfer readiness (when changing Notified Bodies)
Outcome: Fewer surprises, clearer timelines, better outcomes.
How We’re Different from Traditional Firms
| Traditional Approach | Fahmy Consulting Approach |
| One-size-fits-all templates | Tailored, risk-based systems |
| Overdocumentation | Justified, reviewer-friendly evidence |
| Late regulatory engagement | Early regulatory clarity |
| Compliance as a cost | Compliance as an enabler Theory-heavy Execution-focused |
Built for Startups, Trusted by Regulators
Our work is grounded in:
- 16+ years in auditing, consulting, and regulatory compliance
- Deep familiarity with Notified Body expectations
- Real-world experience across manufacturing, pharma, medical devices, and SaMD
- A mindset shaped by regulators, not just standards
We don’t guess what regulators want — we design for it.
When to Engage Fahmy Consulting
- Pre-seed / Seed (regulatory strategy & lean QMS)
- Pre-clinical → clinical transition
- Pre-submission to Notified Body
- Stalled or delayed reviews
- Preparing for scale, acquisition, or funding rounds
The Result
- Faster regulatory decisions
- Fewer review rounds
- Lower compliance cost
- Stronger investor confidence
- Systems that grow with your company