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Fleming Medical Achieves ISO 13485 Certification – Reinforcing Our Commitment to Patient Safety and Quality
15 July 2025
We are proud to announce that Fleming Medical successfully achieved ISO 13485:2016 Certification for the design, development, manufacture, and distribution of Medical Devices. This certification, issued by TÜV Rheinland, is one of the many milestones in our journey, reaffirming our unwavering commitment to patient safety, healthcare excellence, and enduring trust of our partners and customers.
This ISO certification, issued by TÜV Rheinland, covers our operations across the design, development, manufacture, and distribution of Medical Devices—including wound care, patient monitoring, diagnostics, emergency care, and more—strengthening confidence in every product and service we offer.
A Testament to Our Core Values
At Fleming Medical, trust forms the foundation of everything we do. From day one, we have focused on fostering strong, enduring relationships with healthcare professionals, partners, and, most importantly, the patients who depend on our products.
This certification is not just a regulatory milestone—it reflects our commitment to a culture of trust. Every patient, every healthcare professional, and every channel partner should feel assured that they are working with a company rooted in quality, transparency, and reliability. By achieving ISO 13485:2016 certification, we are sending a clear message: we are committed to meeting and exceeding the expectations of modern healthcare, not just today, but for the future.
A Message from Mark Fleming, Founder of Fleming Medical
"At Fleming Medical, we are committed to leading by example. This ISO 13485:2016 certification underscores our dedication to clinical excellence and reinforces the principles that have shaped our company since day one—Leadership, Honesty, Partnership, Trust, Empathy, and Teamwork.
We understand that the medical devices we manufacture and distribute have a direct impact on patient safety and well-being. This certification affirms our responsibility to provide reliable, safe, and effective products that healthcare professionals and patients can depend on.
We are more than just a company; we are a trusted partner in the healthcare community. As we continue to grow, innovate, and support healthcare systems across Ireland and internationally, our core values remain unchanged. We are here to support better patient outcomes, empower clinicians with reliable tools, and ensure that every Fleming Medical product delivers on our standard of quality and care."
Driving Forward – Together
At Fleming Medical, our mission is clear: to deliver high-quality, accessible healthcare solutions that improve lives. As a trusted partner to pharmacies, hospitals, GPs, physiotherapists, and emergency responders, this certification strengthens our role as a key contributor to advancing healthcare excellence worldwide.
Our diverse product portfolio—ranging from the Medicare LifeSense diagnostic devices to PhysioLogix support products and emergency care essentials—reflects our unwavering commitment to quality, now supported by one of the most respected certifications in the medical field.
Visit us at www.flemingmedical.ie/healthcare to discover more about our products and how they can make a difference in the healthcare environment.
