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Medical Device Regulatory Consulting

Navigate Compliance
with Confidence

Specialized regulatory and quality consulting for medical device companies. From QMS implementation to technical files and software validation — we guide you every step of the way.

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What we do

Comprehensive Regulatory Services

End-to-end support for medical device manufacturers navigating complex regulatory landscapes across EU, global, and emerging markets.

Quality Management Systems

Implementation, maintenance, and continuous improvement of QMS documentation in full compliance with international standards. Includes internal audits, management review, and CAPA processes with root cause analysis.

ISO 13485 ISO 9001 MDSAP

Risk Management

Comprehensive risk management files covering hazard identification, risk estimation, risk evaluation, and risk control measures. Full lifecycle management from concept to post-market.

ISO 14971 IEC 81001-5-1

Medical Software Compliance

Full software development lifecycle compliance including requirements, architecture, test cases, IQ/OQ/PQ protocols, and verification & validation for SaMD and medical device software.

IEC 62304 IEC 82304 GAMP 5

CE Marking & Technical Files

Preparation of complete technical documentation for CE marking under EU MDR 2017/745. Device classifications, conformity assessments, clinical evaluations, and post-market surveillance plans.

EU MDR MDD CE Marking

Usability Engineering

Usability Engineering Files encompassing formative and summative evaluations, user needs analysis, task analysis, use error analysis, and usability validation testing.

IEC 62366 Human Factors

Software Validation (CSV)

Validation of quality management software systems including Zoho, Jira, SharePoint, Confluence, Git and more, in compliance with 21 CFR Part 11, EU Annex 11, and ISO/TR 80002-2.

21 CFR Part 11 Annex 11 CSV

GAP Analysis

Systematic assessment of your current quality system against applicable regulatory requirements. Identifies compliance gaps, prioritizes corrective actions, and defines a clear remediation roadmap.

ISO 13485 EU MDR IEC 62304

STRIDE / DREAD Risk Analysis

Cybersecurity threat modelling using STRIDE methodology and DREAD scoring for medical device software. Identifies spoofing, tampering, repudiation, information disclosure, DoS, and elevation risks.

STRIDE DREAD IEC 81001-5-1 CVSS v4

Software Testing

Independent verification and validation of medical device software including unit, integration, system, and regression testing. Traceability matrices, test protocols, and anomaly resolution per IEC 62304.

IEC 62304 V&V IQ/OQ/PQ

Internal Audit Services

Full-scope internal audits of your QMS against ISO 13485, EU MDR, and applicable standards. Includes audit planning, execution, non-conformance reporting, CAPA follow-up, and management review support.

ISO 13485 MDSAP CAPA
Regulatory Expertise

Standards & Frameworks

Deep working knowledge across the full spectrum of medical device regulatory standards, globally.

ISO 13485
Medical devices QMS requirements
EU MDR 2017/745
EU Medical Device Regulation
IEC 62304
Medical device software lifecycle
IEC 82304-1
Health software – product safety
ISO 14971
Risk management for medical devices
IEC 62366
Usability engineering
IEC 81001-5-1
Cybersecurity – health software
IEC 60601
Medical electrical equipment safety
MDSAP
Medical device single audit program
FDA 21 CFR Part 820
Quality system regulation (US)
ISO/TR 80002-2
Validation of software for QMS
GAMP 5
Good automated manufacturing practice
Srđan Đorđević
15+
Years experience
About

Srđan Đorđević
Your Regulatory Partner

Electronic engineer by training and regulatory expert by vocation, Srđan brings over 15 years of hands-on medical device industry experience — from technical support and software validation to quality assurance management and full regulatory consulting.

As external associate at Sigma Consulting Team and founder of EasyMed Consulting, he has guided companies through QMS implementation, CE marking, technical file preparation, software lifecycle compliance, and complex software validation projects.

Certified Lead Auditor (ISO 13485), Internal Auditor (ISO 9001), and MDSAP-certified auditor — with a track record spanning international markets across Europe, Asia, Africa, and the Americas.

Lead Auditor ISO 13485 MDSAP Certified Internal Auditor ISO 9001 Design Control Software V&V Cybersecurity (CVSS v4) AI in Healthcare EU AI Act
LinkedIn Profile
How we work

A Clear Path to Compliance

A structured, transparent engagement process designed to minimize disruption to your development cycles.

Initial Assessment

Review of your current quality system, product portfolio, target markets, and regulatory obligations. Gap analysis against applicable standards.

Strategy & Planning

Tailored regulatory roadmap with clear milestones, deliverables, and timelines. Prioritized action plan aligned with your product development schedule.

Implementation

Hands-on support in preparing documentation, SOPs, technical files, and validation protocols. Training your team on applicable requirements.

Review & Audit Readiness

Internal audit simulation, management review facilitation, CAPA resolution, and pre-certification readiness review.

Ongoing Support

Continuous compliance maintenance, post-market obligations, change management, and surveillance audit support as your trusted long-term partner.

Get in touch

Start Your Compliance Journey

Ready to discuss your regulatory challenges? Reach out directly — response within one business day.

Srđan Đorđević — EasyMed Consulting
Primary email
[email protected]
Business email
[email protected]
Phone / WhatsApp
+381 66 310 429
Office
Rudnicka 4a, 18000 Niš, Serbia
Available for new projects · Mon – Fri, 09:00 – 17:00 CET
What to include in your message
Your timeline
Certification target date or audit deadline if applicable
Area of interest
QMS · CE Marking · Risk Management · IEC 62304 · Usability · CSV · Other
Your company
Brief description of your product and current regulatory status
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