Certifications

U.S. FDA, 510(k)
We have to date received FDA clearance for most of our electrostimulation devices under medical devices Class I, II & III. Every FDA submission is completely prepared in house by our experienced team. Our goal is to not only deliver a high quality product that meets necessary regulatory requirements, but also to produce a product that is safe and effective.

ISO 9001:2008 & ISO 13485:2003
Johari Digital Healthcare Ltd has acquired ISO 9001:2008 certificate in the year 2010.

ISO13485 processes have been built into every stage of our manufacturing and quality assurance functions. We have specialized processes to ensure clean environmental conditions, risk management and traceability—some of the key elements of this standard.

UL, CE
Third-party testing for UL (one of the major regulatory requirements for US) & CE (a mandatory mark for placing a product in European economic Area) is typically done before any significant manufacturing takes place. Our products undergo rigorous testing procedures to comply with the standards associated with UL & CE and prove effective in real life situations.

Standards
Our processes also remain up-to-date to meet the most stringent global standards.

IEC 60601
We conform to the IEC 60601-1 family of standards, the cornerstone document addressing many of the risks associated with electrical medical equipment.

EU & Medical Devices Directive
The MDD and EU directives cover the regulatory requirements of the European Union for Medical Devices to ensure medical products comply with a set of essential requirements relating to performance, health and safety.

Electromagnetic Compatibility (EMC) Directive: EU directive 2004/108/CE

Low Voltage Electrical Equipment Directive: EU directive 73/23/EEC

MDD 93/42/EEC