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News

Design consultancy meets international standard for medical device quality

Cambridge Design Partnership : 26 October, 2014  (Company News)
Following a six-month accreditation review, Cambridge Design Partnership has been awarded ISO13485 and ISO9001 certification for quality management. These qualifications include strict healthcare regulations helping to ensure product safety and efficacy within the medical sector. The company was able to go through the accreditation process rapidly to achieve certification in just six months.
Design consultancy meets international standard for medical device quality

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 in Europe. Cambridge Design Partnership has designed its quality management system to be compliant with this standard, as well as with 21CFR820, the FDA’s quality system regulation in the US. Both these standards confirm that the company can deliver regulatory compliant development programmes for medical devices to healthcare companies in Europe and the US.


 


Working with an ISO13485 compliant partner enables large pharmaceutical and 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 Cambridge Design Partnership’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, Cambridge Design Partnership 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.


 


Cambridge Design Partnership 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 CDP’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, Partner Matt Schumann said, “Major pharmaceutical and medtech clients 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 both Europe and the US.”


 

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