DR DAGA’S AWARDED CERTIFICATION TO ISO 13485:2012 International standard for medical device quality management achieved
DR DAGA’S HEALTH CARE & RESEARCH CENTRE PVT LTD has been awarded certification to ISO13485 , the internationally recognised standards for quality management. As part of a long term commitment to quality, the company was able to go through the accreditation process rapidly to achieve certification in just six months.
In the healthcare sector it is essential that the product development process meets stringent regulatory requirements to ensure product safety and efficacy. ISO13485 defines these requirements and DR DAGA’S HEALTH CARE & RESEARCH CENTRE PVT LTD has designed its quality management system to be compliant with this standard . This standards confirm that the company can deliver regulatory compliant development programmes for medical devices to healthcare companies .
Working with an ISO13485 compliant partner like DR DAGA’S HEALTH CARE & RESEARCH CENTRE PVT LTD enables large medical device companies to minimise the time and cost associated with integrating an external development partner into their own quality management systems. This way programmes can progress more rapidly and quality management occurs seamlessly throughout the project. These companies can be confident that DR DAGA’S HEALTH CARE & RESEARCH CENTRE PVT LTD’s quality management team can provide full technical and design history files for the complete development process from concept insight to manufacture.
For high growth start-ups, DR DAGA’S HEALTH CARE & RESEARCH CENTRE PVT LTD can provide an outsourced product development service with an integrated quality management programme, delivering the product design complete with all the documentation needed for regulatory filings in both Europe and the US.
DR DAGA’S HEALTH CARE & RESEARCH CENTRE PVT LTD has many years’ experience of developing innovative medical devices for global companies, working with some of the largest names in the industry. The ISO accreditation covers all of DR DAGA’s processes, from concept development to verification & validation testing, including stakeholder research, usability engineering, mechanical, electronic and software engineering, as well as supply chain & manufacturing development.
Commenting on the accreditation success, Director Dr Abhay R Daga said, “Major medical devices companies constantly face the challenge of bringing innovative new products to market in the minimum possible time. Our ISO certification gives them the peace of mind to entrust us with their most important product innovation programmes, confident that our documentation can be used directly in regulatory submissions and will withstand scrutiny from the regulatory authorities in all around the world.”