ISO 27001 & ISO 13485 Consultant Needed for AI Health Startup (Implementation + Certification Support)

$15-25 USD / heure

Fermé

Publié il y a 12 jours

$15-25 USD / heure

We are a Swedish health-technology startup developing Astrid, an AI-powered clinical intake platform used inside healthcare clinics to structure patient anamnesis before doctor visits. We are currently preparing for certification and are looking for an experienced ISO consultant who can guide and support us through implementation and certification readiness. We are not looking for a large consulting firm, but a hands-on expert who can work directly with our small technical team. ⸻ Scope of Work We need support with: ISO 27001 (Primary focus) • Establishing an Information Security Management System (ISMS) • Risk assessment & risk register • Security policies and documentation • GDPR-aligned data governance structure • Evidence collection preparation • Audit readiness preparation ISO 13485 (Planning / Early preparation) • Quality Management System (QMS) structure • Documentation framework aligned with medical software workflows • Guidance on regulatory positioning for AI software ⸻ Project Goal Prepare Astrid for: • ISO 27001 certification audit • Future ISO 13485 certification readiness • Healthcare procurement requirements in Europe ⸻ What We Already Have • Active software development team • Defined product architecture • GDPR awareness and secure infrastructure planning • Internal documentation started We need expert guidance to structure everything correctly and efficiently. ⸻ Ideal Candidate • Experience implementing ISO 27001 (required) • Experience with healthtech / medical software (strong plus) • Experience with startups or small teams • Practical implementation mindset (not only advisory) • Familiar with EU GDPR requirements • Experience preparing companies for certification audits

N° de projet : 40258357

Concernant le projet

8 propositions

Projet à distance

Actif à il y a 12 jours

Cherchez-vous à gagner de l'argent ?

Adresse e-mail

Avantages de faire une offre sur Freelancer

Fixez votre budget et vos délais

Soyez payé pour votre travail

Surlignez votre proposition

Il est gratuit de s'inscrire et de faire des offres sur des travaux

8 freelances proposent en moyenne $24 USD/heure pour ce travail

@HiraMahmood4072

Hi, I hope you're doing well. I understand you're looking for ISO 27001 & ISO 13485 Consultant Needed for AI Health Startup (Implementation + Certification Support) I am the ideal candidate for your project. I have read the provided job description and I understand what you are looking for. I have over 10+ years of experience Technical Writing, Report Writing, Research Writing, Medical Writing .Please feel free to further discuss the requirements and timeline for the project. I'd be happy to assist you. I am ready to start right now. ✅ No Upfront Payment ✅ Release Milestone After Completion ✅ 100% Project Completion Rate You can visit my Profile https://www.freelancer.com/u/HiraMahmood4072 Thank you

$20 USD en 40 jours

4,5

(8 commentaires)

4,2

@srmukul2

Hello, I’m Md Shofiur, a cybersecurity consultant (CEH) and CEO of Pentest Testing Corp, with hands-on experience building ISO 27001-aligned security programs for SaaS and cloud products and aligning security practices with GDPR requirements. I can work directly with your small technical team to operationalize an ISMS for Astrid and get you audit-ready without “big-firm” overhead. For ISO 27001, I’ll define ISMS scope, run a risk assessment and build the risk register, establish core policies and procedures, map and implement Annex A controls, and set up practical evidence collection (access reviews, logging, incident response, vendor management, SDLC). I’ll also structure GDPR-aligned data governance (data mapping, retention, DSAR and breach response processes) so compliance is embedded in engineering workflows. We’ll close gaps, run an internal audit/mock audit, and prepare a clear certification-readiness package for your external auditor. In parallel, I can help you plan early ISO 13485 readiness by shaping a QMS structure and documentation framework aligned to medical software workflows, and support your regulatory positioning for AI-enabled clinical intake software. Please feel free to message me privately to discuss your project further. I look forward to the opportunity to work with you. Best regards, Md Shofiur CEO & Founder, Pentest Testing Corp.

$25 USD en 40 jours

5,0

(4 commentaires)

4,0

@RomanSattar

As an ISO and compliance expert, I've not only led numerous organizations through the successful implementation of ISO 27001, but I've also ensured their readiness for certification audits. My experience conducting risk assessments, developing information security policies, and establishing ISMS will be invaluable to your AI health startup. Moreover, my proficiency in GDPR-aligned data governance structures aligns seamlessly with the secure infrastructure planning phase you've already started. Having worked across industries including finance, government, healthcare (specifically with HIPAA compliance), e-commerce, and enterprise sectors, I'm well-versed in addressing various regulatory requirements. This includes familiarizing myself with Europe's healthcare procurement requirements, making me an ideal candidate for your project's scope. Additionally, my background in Linux Hardening & Forensics can provide the required guidance on regulatory positioning for your AI software as outlined in ISO 13485.

$20 USD en 40 jours