Quality Assurance & Regulatory Standing
Panakeia upholds stringent quality assurance standards and full regulatory compliance under the Medical Device Rules (MDR) governed by CDSCO.
Statutory Regulatory Standing Disclosure
Panakeia Medtech Private Limited maintains active CDSCO Medical Device Regulatory Compliance for the design, examination, evaluation, and performance testing of critical care devices (Anaesthesia Workstations & Ventilators).
Our state-of-the-art in-house Visakhapatnam manufacturing facility operates under rigorous quality management and regulatory standards, where all device parts and assemblies are produced directly by Panakeia itself. We maintain strict factual adherence to national and international medical device regulations.
Current Regulatory Credentials & Registrations
All active and pending regulatory credentials maintained by Panakeia Medtech Private Limited.
Make in India MedTech Enterprise Recognition
Issued by: Government of India MedTech & Make in India Initiative
Recognized indigenous medical technology manufacturing entity under Make in India initiative for advancing indigenous critical care OT & ICU equipment design.
CDSCO Medical Device Regulatory Compliance
Issued by: Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services
Adherence to CDSCO regulatory standards for examination, testing, and performance validation of Anaesthesia Workstations and Ventilators at our dedicated in-house manufacturing facility.
Medical Device Manufacturing Standards Compliance
Issued by: State Drugs Control Administration & CDSCO Regulatory Framework
Facility validation, safety protocols, and rigorous quality audit adherence across the Panakeia in-house manufacturing unit.
MSME Udyam Registration
Issued by: Ministry of Micro, Small and Medium Enterprises, Government of India
Registered manufacturing enterprise contributing to India's self-reliance in high-precision critical care biomedical engineering.
ISO 13485:2016 Medical Devices Quality Management System
Issued by: TUV / Accredited Medical Device Registrar
Comprehensive quality management system covering design, manufacturing, assembly, calibration, and servicing of anaesthesia systems and life-support ventilators.
Panakeia In-House Manufacturing Facility
Issued by: Panakeia Medtech Manufacturing Division, Visakhapatnam
Dedicated state-of-the-art facility with all components and parts manufactured in-house by Panakeia itself, featuring rapid prototyping, EMI/EMC compliance testing, and biomaterial testing laboratories.
Multi-Stage Clinical Safety & Calibration Protocol
Every unit and component manufactured in-house by Panakeia itself undergoes thorough multi-point pneumatic and electrical verification before dispatch.
Pneumatic Pressure Testing
High-pressure pipeline testing up to 800 kPa, leak rate decay verification, and anti-hypoxic mechanical interlock verification.
IEC 60601-1 Electrical Safety
Earth leakage current, dielectric breakdown insulation resistance, and secondary power supply battery endurance stress tests.
Flow & Tidal Volume Precision
Micro-calibrated against certified reference gas flow analyzers across ambient temperature and barometric variations.
Continuous 72-Hour Burn-In
Extended mechanical ventilation cycling on artificial lung simulators under continuous maximum respiratory resistance.