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I will draft your samd regulatory strategy and eu ai act compliance
Zakir H.
About this gig
Bridge the gap between Tech and Regulation with an auditor's expertise.
The 2026 enforcement of the EU AI Act has created a massive challenge for SaMD startups. If your software uses AI for diagnostics or treatment, you are likely "High-Risk." I help you navigate the intersection of Medical Device regulations (MDR/FDA) and the new AI mandates.
What I provide:
- Classification Analysis: Determination of SaMD Class (I, IIa, IIb, III) and AI Act tier.
- ISO 62304 Compliance: Strategy for software lifecycle processes.
- AI Act Readiness: Documentation strategy for "High-Risk" AI systems.
- FDA 510(k) Pre-market Strategy: Roadmap for US market entry.
Why me?
I am an Engineer and Auditor who understands code and compliance. I don't just give you a checklist; I give you a clear path to market that protects your innovation.
Please message me with your software's intended use before ordering.
Get to know Zakir H.
Zakir H.
Regulatory Affairs Specialist
- FromPakistan
- Member sinceJan 2026
- Avg. response time1 hour
- Last delivery4 months
Languages
English
I’m Zakir, a MedTech Regulatory Specialist and ISO Lead Auditor with 10+ years of experience. Based in Canada, I specialize in EU MDR (2017/745) and IVDR compliance for Class I through Class III medical devices.
I help manufacturers navigate the complex path to CE Marking by delivering audit-ready Technical Files (STED), CERs, Risk Management (ISO 14971), and PMS/PMCF documentation. My unique perspective as an auditor ensures your documentation is structured to pass Notified Body reviews with zero friction. Let’s secure your market clearance.
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FAQ
How do I know if my software is considered "High-Risk" under the EU AI Act?
Generally, if your AI is used as a medical device (SaMD) or as a safety component of one under the MDR/IVDR, it is likely classified as "High-Risk." I will perform a formal assessment to determine your specific tier and the resulting documentation obligation
Does this roadmap cover both the EU MDR and the US FDA 510(k)?
Yes. While the EU AI Act is a major focus for 2026, I provide a dual-market strategy. I align your software lifecycle (ISO 62304) and risk management (ISO 14971) to satisfy both Notified Bodies in Europe and the FDA in the United State
Do you provide the actual Software Requirement Specifications (SRS)
This Gig provides the Regulatory Strategy and Gap Analysis. I define what needs to be in your SRS and Architecture to be compliant. If you need me to draft the full technical documentation suite, please message me for a custom project propo
