Our story
25 Years of Engineering Devices That Clinicians Trust
Founded in 1999, MedCore Devices has grown from a single-product startup into a globally recognized manufacturer of precision medical equipment — without ever compromising on the standards that protect patients.
Mission & values
Built on a Simple Principle: Precision Saves Lives
Every device we design, manufacture, and deliver is held to the same standard — it must perform flawlessly in the hands of a clinician, every single time. That commitment drives every decision we make, from materials sourcing to final quality inspection.
Uncompromising Quality
We exceed regulatory minimums because our customers' patients deserve nothing less.
Global Reliability
Consistent performance across 40+ countries and every climate condition.
Distributor Partnership
We treat our distributors as long-term partners, not just sales channels.
Continuous Innovation
R&D investment that keeps our product range ahead of clinical demands.
Our history
From Startup to Global Manufacturer
MedCore founded in Chicago with a focus on diagnostic instruments for outpatient clinics.
Achieved ISO 13485 certification and launched first surgical instrument line.
Expanded into European markets following CE marking of core product range.
Opened state-of-the-art manufacturing facility with Class 7 clean room.
Reached 500+ product SKUs and established distributor network in 40 countries.
Launched next-generation imaging systems line; WHO prequalification achieved.
Regulatory compliance
Certified to the Highest International Standards
Our quality management system and product portfolio are certified and registered across all major regulatory frameworks.
ISO 13485:2016
Medical devices quality management systems — full facility certification
FDA Establishment Registration
U.S. Food & Drug Administration facility registration #3012345678
CE Marking — MDR 2017/745
European conformity under the EU Medical Device Regulation
ISO 9001:2015
General quality management system — design, manufacturing, and distribution
WHO Prequalification
World Health Organization product prequalification for select diagnostic devices
Health Canada License
Medical device establishment license for Canadian market distribution
Leadership
Led by Experts in Medical Engineering and Global Distribution
20+ years in medical device development and global regulatory strategy.
Former VP of Operations at a Fortune 500 medical manufacturer; expert in lean production.
Leads global compliance across FDA, CE, and WHO frameworks for all product lines.
Built MedCore's distributor network across 40+ countries over 15 years.
Partner with a Manufacturer You Can Rely On
Join our global distributor network and gain access to certified products, dedicated support, and competitive pricing.