As part of our commitment to quality, safety, and ethical deployment, SlimIoT is actively pursuing all relevant Indian and international certifications required for medical and consumer health devices. Our goal is to ensure each device meets or exceeds the regulatory standards for its intended use, from Class A wellness trackers to Class C diagnostic tools.
Medical Device Regulations
CDSCO (Central Drugs Standard Control Organization) – For devices classified under Class A to C, including ECG and PPG sensors, fall detection, and vital sign monitors.
BIS Certification – For product safety, quality control, and electrical compliance under Indian Standards.
Clinical Standards and Protocols
ISO 7250, ISO 81060-2 – Validation of physiological parameters like SpO₂, HR, BP.
Comparison Testing – Heart rate against ECG; respiration against gold-standard monitors.
ICMR- and NABL-accredited Labs – Identified for clinical testing and validation.
Electrical Safety: IS 13252, IS 16046, IEC 60601-1
EMC (Electromagnetic Compliance): IS 616, IEC 62133
Wireless Communication: WPC Approval, IEEE 802.15, Bluetooth, Wi-Fi
Medical Software: IEC 62304
Biocompatibility & Wearability: ISO 10993
Battery Transport & Safety: UN38.3, RoHS, WEEE Compliance
SlimIoT products collect personal health data and are designed in compliance with:
IT Act 2000 + SPDI Rules
ISO 27001 for Information Security
Draft Personal Data Protection Bill (PDPB) preparedness
Support for GDPR and HIPAA equivalent structures in future rollouts
Pre-market licensing for Class B/C devices via CDSCO
Clinical validation with ICMR/NABL-accredited labs
BIS product safety clearance across all consumer and medical form factors
Establish internal ISO 13485 QMS for scalable and audit-ready manufacturing
Adopt RoHS/WEEE for global environmental sustainability
