We recently passed our annual certification audits for ISO 13485 and ISO 9001 – international standards that recognise quality management and demonstrate our long term commitment to providing the best quality for our clients.
Since implementing the ISO 13485 standard over the past twelve months, we have expanded our portfolio of medical clients and designed and produced a range of medical devices we’re incredibly proud of, taking clients from initial concept, through certification, and finally to market launch. During the recent Covid-19 crisis, we’ve designed and produced forearm opening door handles to support the NHS in a tight timeframe, at the end of last year we also designed an in-mask prescription optics attachment for respiratory masks for Corpro. These medical designs, and others we’ve produced, are all making lives easier, if not saving lives.
There are many strict regulatory requirements within the healthcare sector with regards to product design to ensure product safety and efficacy. ISO 13485 defines these requirements in Europe and we have designed our quality management systems to be compliant with this standard.
Importantly, these accreditation’s mean we can deliver regulatory compliant development programmes for medical devices to healthcare companies in Europe. For larger organisations, this can mean integrating as an external partner into their own quality management systems. For medical start-ups, we can provide an outsourced product development service with an integrated management programme. In both cases, we deliver a complete product design service with all the necessary regulatory filings in Europe.
In addition we also have the ISO 9001:2015, which is based on a number of quality management principles including a strong customer focus, motivation and implication of top management, the process approach and continual improvement. Working with us, all of our clients are guaranteed the best quality products and services, with a more rapid and seamless design process through every stage.
If you’re interested in speaking to us about the design of a medical device, or would like more information about ISO 13485 and ISO 9001, please get in touch