Certifications
Excellence is our guide. At Heka Medicals, our top priority is only quality.
FORM MD-5
The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
ISO 13485:2016
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Patent No: 431088
ICMED 13485
ICMED is India’s first medical devices quality management system which is the joint voluntary initiative between AiMeD (Association of India Medical Device Industry), QCI (Quality Council of India) & NABCB,
IEC 60601-1
International standard for safety and essential performance of medical electrical equipment.
IEC 60601-1-2
Collateral standard that provides the requirements for essential performance and basic safety in the presence of electromagnetic disturbances.
Drop Test
FCRI is a premier institute in Fluids Engineering in South East Asia for R&D on flow products, Testing and Calibration of Valves, flow meters and other measuring instruments as per ISO requirements
Calibration report
FCRI is a premier institute in Fluids Engineering in South East Asia for R&D on flow products, Testing and Calibration of Valves, flow meters and other measuring instruments as per ISO requirements
Vibration Test
Standardisation Testing and Quality Certification (STQC) Directorate is an attached office of the Ministry of Electronics and Information Technology, Government of India, provides quality assurance services in the area of Electronics and IT through countrywide network of laboratories and centres.
ISO 80601-2-74:2021 applies to the basic safety and essential performance of a humidifier, also referred to as ME equipment, in combination with its accessories, the combination also referred to as ME system. This certification is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier.
