ISO 13485 Consultants in Bangalore – Karnataka
Inzinc Consulting India team consists of expert ISO 13485 Consultants in Bangalore, Karnataka ensure the planning, documentation, implementation, maintenance and continual improvement of Quality Management System for Medical Devices (QMS-MD) as per the clauses laid out by the ISO 13485:2016 Standard.
We take special interest and closely work with our Customers, guide them, make them thoroughly understand the advantages of the ISO 13485 system. In this manner, our Client organizations can put a solid foundation upon which they can keep realizing continual improvements.
About ISO and the ISO 13485 Standard
ISO when expanded is the International Organization for Standardization. ISO has its Headquarters in Geneva, Switzerland. ISO is an independent and Non-governmental Organization that publishes International Standards on various fields both technical and management. One such standard is the ISO 13485 Quality Management System standard for Medical Devices.
The ISO 13485 standard on Quality Management System for Medical Devices specifies the requirements for establishment, implementation, maintenance and continual improvement of a Quality Management System for Businesses in one or more stages of the Medical Device Life-cycle. The ISO 13485:2016 standard is the latest version and was published in March 2016. This version cancels and replaces the 2003 version which was the first edition of ISO 13485 standard. Our team of ISO 13485 consultants in Bangalore, Karnataka ensure that we do a good job and get our Client Organization certified to ISO 13485:2016 in reasonable time period.
About Medical Devices
Medical Devices are devices used for Medical purposes and more importantly saves and supports life. Some of the examples of Medical Devices are Nebulizers, infusion pumps, Catheters, Cardiac Stents, Pacemakers, various types of implants, and In-vitro diagnostic medical devices like the Glucose test kits or reagents, etc.
In all the Medical Devices, Quality needs to meet the highest standards since these are used to save and support lives. Therefore, the ISO 13485 needs to be thoroughly implemented by Organizations who are involved in the design, development, manufacturing, packaging / labelling, sale / distribution, servicing and importing of Medical devices. ISO 13485 can provide the framework for Organizations to standardize its processes to achieve Quality, reliability, safety and performance.
In the Indian scenario, the ISO 13485 standard is mandatory to obtain license for Organizations who intend to manufacture / import Medical Devices.
Our ISO 13485 Consultants in Bangalore, Karnataka will assist you in implementing the ISO 13485 Standard in reasonable and mutually agreed timelines.
ISO 13485 Benefits
Organizations can obtain the following benefits by implementing the ISO 13485 standard:
- Through robust processes, Organizations can enhance the safety and performance of the Medical Devices
- Help obtain license to manufacture / import Medical Devices in India. It also helps in complying with other regulations applicable to the Organizations
- Will help deal with business uncertainties through Risk Management
- Realize benefits of implementing best practices in the Organization
- By following the PDCA (Plan – Do – Check – Act) cycle for the system and the processes, continual improvements can be made.
- Wastes in the form of defects and errors can be minimized.
- Monitoring and measurement of processes along with audits act as a check for analyzing performance and correcting the short falls.
- Achieve business objectives and process level objectives more consistently with the help of Risk Management.
Our scope of ISO 13485 Consulting
Our scope of ISO 13485 Consulting covers the documentation, training, implementation guidance, conducting audits or help conduct audits and guidance on conducting Management Review Meetings (by our Client’s Top Management). Our ISO 13485 Consultants in Bangalore, Karnataka also help in resolving the Non-conformities and take the necessary Corrections and Corrective actions.