About Us
Qualitech International is a premier regulatory and testing partner for the global medical device industry. We bridge the gap between groundbreaking medical innovation and strict global compliance.
Since 2006
Qualitech International is a specialist regulatory and technical consulting firm dedicated exclusively to the medical device and in vitro diagnostics (IVD) industries. Founded in 2008, we have spent nearly two decades helping manufacturers, distributors, and innovators navigate the complex regulatory landscape — from initial concept and design through clinical evaluation, market authorisation, and post-market surveillance.
With offices in the United Kingdom, the United States, Canada, Egypt, and the Netherlands, we operate as a truly global partner — providing on-the-ground expertise in the jurisdictions that matter most to our clients.
Mohamed Mahdy
Ghonim Mohamed, Founder & CEO
Our Mission
To empower medical device manufacturers with scientifically robust testing and strategic regulatory guidance, ensuring safe, effective, and compliant healthcare solutions reach patients worldwide without delay.
Our Vision
To be the globally recognized gold standard in medical device compliance and testing, driving the future of healthcare innovation through uncompromising quality and expertise.
What We Do
Our service portfolio spans the full product lifecycle, delivered by a multidisciplinary team of engineers, scientists, and regulatory affairs professionals:
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Authorized Representation
Legal representation including EU-REP, UKRP, CH-REP, and US Agent.
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Regulatory Affairs
Expert guidance for MDR, IVDR, FDA, and global regulatory pathways.
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Quality & Risk Management
Expert support for ISO 13485, ISO 14971, and usability engineering.
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Technical Documentation
Expert Technical File preparation aligned with MDR/IVDR requirements.
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Clinical Evaluation
Comprehensive CERs and evidence reviews for safety and performance.
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Calibration & Validation
Reliable calibration for medical and laboratory equipment accuracy.
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Microbiological Testing
Precise testing ensuring product safety and compliance.
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Biocompatibility Test
Ensuring medical device compatibility with living tissue.
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Package Validation
Ensuring packaging maintains product sterility and integrity.
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Stability Study
Assessing product shelf life and long-term stability.
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Training Programs
Specialized workshops covering MDR/IVDR, QMS, and risk management.
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Scientific Translation
Precise, regulation-compliant translations for technical and clinical documents.
Certified Excellence
Quality is not an afterthought at Qualitech International — it is the foundation of every engagement. Our operations and laboratory services are underpinned by internationally recognised accreditations:
UK, US, Canada, Egypt, Netherlands
Supported Worldwide
Deep Regulatory Expertise
Conducted Globally
Trusted by Over 500 Businesses Worldwide
Over the years, Qualitech International has built a solid global reputation by transforming complex regulatory hurdles into clear, actionable paths to market. Our numbers represent our commitment to quality, compliance, and clinical safety for medical devices worldwide.
Why Qualitech International?
- Nearly two decades of focused expertise in medical devices and IVD regulation
- Single-source solution for validation, biocompatibility, risk management, and global representation
- Deep knowledge of EU MDR/IVDR, FDA, Health Canada, and UKCA regulatory frameworks
- Globally distributed team providing responsive, in-jurisdiction support
- Accredited, independent, and wholly committed to client success
- Proven track record supporting start-ups, SMEs, and global multinationals
