Medical Devices Quality
Johari Digital Healthcare is committed to meeting customer, statutory and regulatory requirements and increasing customer satisfaction through continual improvement of its products, services and it’s Quality Management System. At Johari Digital Healthcare, we give prime importance to Medical Devices Quality. We understand that quality standards are of paramount importance for medical products, so test procedures are given the utmost attention in developing each of our world class products. Every unit undergoes a number of strictly supervised quality tests for precision, performance and safety. Our processes also remain up-to-date to meet the most stringent global standards. The organization is committed to maintaining the effectiveness of the Quality Management System by means of internal audits, management reviews and corrective action and preventive action procedures for any Quality Management System non-conformances.
Quality is active and ongoing at Johari Digital Healthcare and not a static statement. A summary of the quality and regulatory accomplishments to date is as below. We proud to provide any of the below certificates for clients review and decision making process.
- ISO 13485:2016 – Medical Device Manufacturing
- Compliant with ISO 9001 – Product Design and Manufacturing
- FDA Registered Manufacturing facility
- FDA 510(k) approvals
- Health Canada Audit: ISO13485 : CMDCAS
- Australian Therapeutic Registration (Australia, TGA)
- CE Lab testing capabilities and CE certificates
- UL Lab testing capabilities and UL certificates
- IEC 60601 standards
- PCB XXX standards
Johari Digital Healthcare’s Quality Values and Beliefs are woven through all departments and functions of the organization and there is great pride in the products and service provided. The top management of Johari Digital Healthcare continually assesses all operations in an effort to improve performance and satisfaction of customer requirements.