Medical Devices
INCREASE supports medical device manufacturers through clinical investigation design, Clinical Evaluation Report (CER), post-market follow-up, and Software as a Medical Device (SaMD) evaluation in line with international standards.
Aligned with
Key Capabilities
Regulatory-aligned clinical evidence generation for Class I–III devices and software-driven products.
Clinical Investigation Design
Development of study design aligned with ISO 14155 and applicable MDR.
Clinical Evaluation Report (CER)
Clinical evaluation and literature appraisal per MEDDEV 2.7/1 and MDR.
Post-Market Follow-Up
PMCF plans, surveillance, and reporting.
SaMD & Digital Health
Evaluation of Software as a Medical Device.
Usability Engineering
Human factors and usability validation studies.
Site & Investigator Network
Qualified device-trial sites and investigators.
Regulatory Strategy
Navigate regulatory pathways according to applicable MDR (AMDD or MoH).
Risk Management
Risk assessment and mitigation planning aligned with ISO 14971 standard.
Data Management
eCRF, EDC, and submission-ready clinical data packages.
Protocol Writing (CIP)
Clinical investigation plans per ISO 14155 and applicable standards.
Integrated Laboratory
Lab & Diagnostic Services
Backed by our in-house central laboratory — samples processed on site for faster turnaround and unified data.
Clinical Pathology
Clinical Microbiology
Anatomical Pathology
Cell-based Assay
Ready to discuss your Medical Devices program?
Our integrated team is ready to design a study tailored to your development goals.