Acumentia’s technical consultants are on hand to pro-actively guide clients through the complicated network of quality control procedures and regulatory bodies that govern the medical device manufacturing industry. Our quality and regulatory experts have a broad understanding and experience of the key western markets, including the EU, USA and Canada; it is our mission to ensure that your ground-breaking medical device technology consistently enters the market to strict budgets and tight deadlines.
The key to any healthy production line is a strong quality management system, which doesn’t only make sure your products receive the appropriate accreditation, but also reassures your customers of their durability and longevity. We devise bespoke quality management systems that are uniquely tailored to your business, ensuring both profitability and efficiency at a production rate to suit your organisation. We have also previously helped clients achieve ISO 13485:2003, the international quality standard of medical devices.
Although originally developed in Europe, the CE mark is widely recognised as a hallmark of professional design and industry beating quality throughout emerging markets across the globe. Our technical consultants have successfully CE marked a wide range of medical devices by providing advice on subjects like risk management, biocompatibility and technical file compilation at all stages of the design and manufacture process.
The service that Acumentia offers is unique because it’s underpinned by the extensive experience of both our food science and pharmaceutical specialists; our unprecedented understanding of how to take industry-changing products to market, such as drug delivery systems or food supplement devices, has previously benefitted many organisations both within and outside of the EU.