UCOS TECHNOLOGY & CONSULTANCY

Expert Consulting.
Your Regulatory Partner in the EU.

From EU market access and medical device compliance to cybersecurity and AI governance — we provide end-to-end regulatory consulting backed by 17+ years of industry experience and a proven track record of successful Notified Body audits.

Explore Services ↓
17+
Years Industry Experience
54+
Standards & Frameworks
EU · US · APAC
Market Coverage
4
ISO Lead Auditor Certifications
WHAT WE DO

Comprehensive Regulatory Services.

Whether you need EU market access, compliance support, or a complete quality management system — we have you covered.

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SERVICE 01
EU MARKET ACCESS

Your Legal Gateway to Europe

We act as your EU Authorized Representative and Person Responsible for Regulatory Compliance — your official regulatory presence in the European Union.

  • ✓EU Authorized Representative (EU REP) under MDR Article 11
  • ✓Person Responsible for Regulatory Compliance (PRRC) under MDR Article 15
  • ✓EUDAMED registration and device registration management
  • ✓CE Marking coordination with Notified Bodies
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SERVICE 02
MEDICAL DEVICE COMPLIANCE

End-to-End Regulatory Support

From technical documentation to post-market surveillance — we cover the full lifecycle of your medical device regulatory compliance.

  • ✓EU MDR 2017/745, ISO 13485, MDSAP multi-market compliance
  • ✓Technical Documentation preparation, review and remediation
  • ✓Clinical Evaluation Report (CER) writing and updates
  • ✓Post-Market Surveillance (PMS), PMCF plans and PSUR reporting
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SERVICE 03
CYBERSECURITY & AI GOVERNANCE

Securing Compliance in the Digital Age

With certified Lead Auditor expertise in ISO 27001 and ISO 42001, we help organizations implement and maintain information security and AI governance systems.

  • ✓ISO/IEC 27001 Information Security Management System implementation and audit
  • ✓EU AI Act compliance readiness and gap analysis
  • ✓ISO/IEC 42001 AI Management System setup and certification support
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SERVICE 04
QUALITY MANAGEMENT

Building Quality Systems That Work

We design, implement and maintain quality management systems that pass audits and drive real operational improvement.

  • ✓ISO 9001 / ISO 13485 QMS setup, optimization and transition
  • ✓Outsourced QA/RA Department — your virtual quality team
  • ✓Supplier Audits — remote and on-site across the EU
  • ✓Training — internal auditor, MDR awareness, risk management
ABOUT US

17 Years on the Front Lines of Compliance.

Our consultants bring deep, hands-on experience in global medical device regulation, quality assurance, and Notified Body auditing. We don't just understand the regulations — we've spent years enforcing them.

OUR TEAM'S BACKGROUND
  • →Global medical device manufacturers
  • →Notified Bodies (EU MDR/MDD)
  • →Fortune 500 healthcare companies
  • →Regulatory consultancies across EU, US & APAC
CERTIFICATIONS
  • ✓ISO 13485 Lead Auditor (BSI)
  • ✓ISO 9001 Lead Auditor (BSI)
  • ✓ISO/IEC 27001 Lead Auditor (BSI)
  • ✓ISO/IEC 42001 Lead Auditor

"We work closely with R&D, regulatory, quality, and clinical teams to embed sustainable compliance and accelerate safe market access."

FAQ

Common questions, answered.

What is an EU Authorized Representative and do I need one?+

If your company manufactures medical devices outside the EU and wants to sell in the European market, EU MDR Article 11 requires you to designate an EU Authorized Representative. We serve as your official regulatory presence in the EU — handling authority communications, maintaining your technical documentation, and managing EUDAMED registrations.

What standards and regulations do you cover?+

We cover EU MDR 2017/745, ISO 13485, ISO 14971, IEC 62304, MDSAP, FDA QMSR, ISO 9001, ISO/IEC 27001, ISO/IEC 42001, and the EU AI Act. Our expertise spans 54+ regulatory frameworks across medical devices, cybersecurity, and AI governance.

Can you act as our outsourced QA/RA department?+

Yes. Many startups and small manufacturers don't need or can't afford a full-time QA/RA team. We become your virtual QA/RA department — handling your quality system, regulatory submissions, audit preparation, and ongoing compliance monitoring. You get senior-level expertise at a fraction of the cost of in-house staff.

Do you support non-EU manufacturers entering the European market?+

Absolutely. This is one of our core services. We provide the complete package: EU REP designation, PRRC services, CE marking coordination, technical documentation review, Notified Body liaison, and EUDAMED registration. We become your single point of contact for EU market access.

What is ISO 42001 and why does it matter?+

ISO/IEC 42001 is the international standard for AI Management Systems. With the EU AI Act now in force, organizations developing or deploying AI systems need to demonstrate responsible AI governance. We are among the few consultancies with certified ISO 42001 Lead Auditor expertise to help you implement this system.

How do your supplier audits work?+

We conduct supplier audits both remotely and on-site across the EU, based on ISO 13485, ISO 9001, and ISO/IEC 27001 requirements. Our Lead Auditor certifications ensure your audit reports are recognized by Notified Bodies and regulatory authorities.

What industries do you serve?+

While our core expertise is medical devices, our ISO 9001, ISO 27001, and ISO 42001 certifications enable us to serve any regulated industry — including SaaS companies, fintech, biotech, and general manufacturing.

Where are you located?+

UCOS Technology & Consultancy is headquartered in Istanbul, Turkey with operational presence in the Netherlands, EU. This dual presence allows us to serve both EU and non-EU clients effectively, with cost-efficient operations and direct EU market access.

GET IN TOUCH

Let's Work Together.

Whether you need EU market access support, compliance consulting, or a regulatory strategy discussion — reach out. We respond within 24 hours.

📍Istanbul, Turkey · Netherlands, EU
CONSULTING ENGAGEMENTS

All engagements are scoped individually. We don't display fixed rates — every client situation is unique. Contact us for a tailored proposal.