Case Studies
Medical device case studies. Proven regulatory outcomes.
Our medical device case studies show how I3CGlobal has guided medical device and IVD manufacturers through FDA clearance, EU MDR and IVDR CE marking, clinical evaluation and quality system certification.
Browse medical device case studies by service
United States
13projects
FDA 510(k) Clearance
510(k) submissions that secured US market clearance across implants, consumables and software.
- Total knee replacement system
- Pedicle screw system
- Absorbable surgical sutures
European Union
7projects
EU MDR CE Marking
Technical documentation and CE marking under Regulation (EU) 2017/745.
- Insulin pump
- Defibrillator
- Infant warmer
European Union
4projects
EU IVDR CE Marking
IVD technical files and CE marking under Regulation (EU) 2017/746.
- Syphilis ELISA kit (Class D)
- Self-testing glucose monitoring system
- ADA assay kit
EU MDR
2projects
Clinical Evaluation (CER)
Clinical evaluation reports that demonstrate safety, performance and clinical benefit.
- Automatic resuscitator (Class IIb)
- Software as a Medical Device
Quality Systems
5projects
ISO 13485, QMSR & IEC 62304
Quality management system and software lifecycle implementation for certification.
- Sterile device manufacturer
- Dental devices (21 CFR 820 QMSR)
- Medical device software