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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

The patent has been granted to the patentee for an invention entitled IOT ENABLED NOVEL HIGH FLOW NASAL OXYGEN DELIVERY SYSTEM  for the term of 20 years from the 29th day of April 2021 in accordance with the provisions of the Patents Act,1970.

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

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.


Awards and Recognitions

BIOTECHNOLOGY IGNITION GRANT SCHEME (BIG) AWARD - 2020

The Biotechnology Ignition Grant (BIG) is a flagship scheme of Biotechnology Industry Research Assistance Council (BIRAC) which recognizes and invests in innovative ideas in the biotech sector. 

WINNER, KERALA STARTUP MISSION 
IDEA GRANT - 2021

Grants provided for startups who are in Ideation & Designing Stage/Proof of Concept  Stage to the Minimum viable prototype.

WINNER, KERALA STARTUP MISSION PRODUCTISATION GRANT - 2022

Grants provided for startups who are looking to convert the Minimum viable prototype into the final product with early traction/ early revenue.