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I will do eu mdr technical file remediation
Zakir H.
About this gig
Stop risking Notified Body rejection. Ensure your medical device reaches the EU market with an auditor's oversight.
With 2026 MDR milestones for Class III and implantable devices looming, "good enough" documentation isn't an option. As a Lead Auditor and Regulatory Specialist (Engineering background), I provide the rigorous scrutiny needed to catch gaps before Notified Bodies do.
What I Offer:
- GSPR Analysis: Full review of Safety & Performance Requirements.
- Technical Docs: Device Description, Design, and Manufacturing info.
- Benefit-Risk & CEP/CER: Clinical evidence alignment.
- Post-Market Surveillance: PMS/PSUR robustness.
- Labeling & IFU: Compliance with language/regulatory standards.
Why Choose This Gig?
- Auditor Insight: I see what Notified Bodies look for.
- Engineering Logic: Precision in Risk Management (ISO 14971).
- Actionable ROI: You get a prioritized roadmap, not just a list of errors.
Stop risking rejection. Let's secure your EU market access.
Please message me to discuss your device class before ordering.
Get to know Zakir H.
Zakir H.
Regulatory Affairs Specialist
- FromPakistan
- Member sinceJan 2026
- Avg. response time1 hour
- Last delivery1 week
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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Other Regulatory Compliance Consulting Services I Offer
FAQ
What documents do I need to provide to start?
To perform a thorough Gap Analysis, I typically require access to your current Technical File (Annex II/III), including the GSPR, Risk Management File, and Clinical Evaluation Plan/Report. All documents are handled with the highest level of professional confidentiality.
Does this Gig include the actual rewriting of my technical documents?
This Gig focuses on a comprehensive Gap Analysis and a Remediation Roadmap. It identifies exactly what is missing or non-compliant. If you require "hands-on" drafting or full file remediation, please message me for a custom offer based on the complexity of your device.
