Engineering Better Healthcare Through Technology

Osmiler is a healthcare technology company focused on biosensing, wearable devices, embedded systems, and connected health solutions.
MISSION & VISION

Technology Should Make Healthcare More Continuous, Accessible, and Intelligent.

We believe the future of healthcare will increasingly rely on smaller, smarter, and more connected technologies that can capture meaningful physiological data in everyday environments.
OUR VISION
Intelligent physiological sensing
as a natural part of everyday healthcare.
ENGINEERING TEAM

Built by a Multidisciplinary Engineering Team

Osmiler brings sensing, electronics, embedded software, algorithms, mechanical design, and digital applications into one integrated engineering workflow.

Biosensing & Signal Acquisition

Optical sensing, physiological signals, sensor integration

Electronics & Embedded Systems

Low-power hardware, firmware, wireless systems

Algorithms & Data Processing

Signal processing, physiological analysis, data interpretation

Product & Digital Engineering

Industrial design, mobile applications, cloud-connected systems

Quality Is Built Into
Every Stage of Development

Quality is not treated as a final inspection step.
It is integrated throughout product definition,
engineering development, verification, and production.
Requirements
Define user needs and product specifications
Design
Engineering design and risk management
Verification
Rigorous testing to ensure performance and safety
Validation
Ensure the product meets user needs and intended use
Production
Controlled manufacturing and continuous improvement

Engineered for global market readiness.

ISO 13485QUALITY MANAGEMENT
ISO 13485:2016Medical device quality management
CEEuropean conformity pathway
IEC 60601MEDICAL ELECTRICAL SAFETY
IEC 60601-1Medical electrical safety
FCCRadio and EMC · United States
ISO 14971RISK MANAGEMENT
ISO 14971:2019Medical device risk management
RoHSRestriction of hazardous substances
IEC 62304SOFTWARE LIFECYCLE
IEC 62304Medical device software lifecycle
UKCAGreat Britain market marking
FDA QMSR21 CFR PART 820
FDA QMSRUS medical device quality system
Bluetooth QualificationBluetooth SIG qualification pathway
ISO 10993BIOLOGICAL EVALUATION
ISO 10993-1Biological evaluation framework
WEEEWaste electrical equipment marking
EU MDR2017 / 745
EU MDREU medical device regulation
RCMAustralia and New Zealand
MDSAPSINGLE AUDIT PROGRAM
MDSAPMedical device single audit program
KCKorea market certification
IEC 62366USABILITY ENGINEERING
IEC 62366-1Medical device usability engineering
CCCChina compulsory certification
ISEDCANADA
ISED CanadaRadio compliance · Canada
PSEElectrical safety · Japan
ISO 13485QUALITY MANAGEMENT
IEC 60601MEDICAL ELECTRICAL SAFETY
ISO 14971RISK MANAGEMENT
IEC 62304SOFTWARE LIFECYCLE
FDA QMSR21 CFR PART 820
ISO 10993BIOLOGICAL EVALUATION
EU MDR2017 / 745
MDSAPSINGLE AUDIT PROGRAM
IEC 62366USABILITY ENGINEERING
ISEDCANADA

Relevant pathways vary by product classification and target market. Marks shown do not represent certification status.