MedTech Consulting & Engineering · 20+ Years Experience

Expand your expertise in delivering high-quality MedTech outcomes

Automate compliance, streamline product development, and scale quality with QualityCert.

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20+ years of MedTech experience across Bosnia and Herzegovina, the EU, and the US.

What We Do

Services built for regulated MedTech environments

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Management Systems Consulting

ISO 13485, ISO 9001, GDP, internal audits, outsourcing management, and eRecords/FDA 21 CFR Part 11 support for medical device manufacturers and distributors.

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Product Development Support

Design controls, risk management, usability engineering, technical documentation, verification & validation planning, and CE/MDR readiness.

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BPM for Digital transformation

Process standardization, workflow digitalization, DPPI/AI enablement, and ISO/IEC 42001 readiness.

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MVP Lab

Rapid MVP development for MedTech and healthtech ideas — from concept to a testable prototype, built with ISO 13485 and MDR requirements in mind from day one.

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Expertise across key areas

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ISO 13485 & QMS MDR/IVDR & CE Marking Product Development GDP & Distribution Audits & Supplier Management Pharmacy Quality & AKAZ Systems Technical Documentation Training & Competence Process Digitalization AI Management Systems (ISO 42001)

Why organizations choose QualityCert

Senior Expert Involvement

Direct access to experienced consultants with proven track records — not a junior team behind a brand.

MedTech-Focused Approach

Deep understanding of MedTech regulations, standards, and industry realities, not generic ISO implementation.

Practical Implementation

Solutions that work in real life and deliver measurable business value, from documentation to daily operations.

International Project Experience

Successful projects across Bosnia and Herzegovina, the EU, and the United States for organizations at every stage of maturity.

QualityCert Education

Training that keeps your quality system alive

Since 2018, we've delivered continuous in-house and public training for medical device manufacturers, distributors, and healthcare organizations across the region. Education isn't a side offering — it's how knowledge stays active in day-to-day practice.

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In-House Seminars

Tailored to your organization, products, processes, and risks.

Public Seminars

Standardized one- and multi-day programs with open enrollment for manufacturers, distributors, wholesalers, and healthcare institutions.

Partner Seminars

Delivered together with relevant professional and institutional organizations.

Project Team Training

Focused workshops for project teams during a consulting implementation.

Packaged Company Programs

Attendance tracking, knowledge checks, and a summary report for the client organization.

ISO 13485 & QMS Internal Auditors GDP Materiovigilance Risk Management Technical Documentation Validation CE Marking & Regulatory Compliance Process Mapping Pharmacy Safety Systems Outsource Management