Medimetrics Confirms Capability for Design and Delivery of Medical Devices and Related Services
Product News Mar 22, 2012
This international standard bestows official recognition on the company for its quality management system governing the design, fabrication, and delivery of medical devices and related services.
This comes less than a year since the company secured CE approval for the development of IntelliCap ‒ its unique personalised drug delivery and monitoring system ‒ further opening the way for the device’s use in a clinical setting. As Dr Olaf Weiner, chief executive officer of Medimetrics, explained: “The Medimetrics business solution is far wider than simply providing a device for use in the delivery of drugs. Gaining ISO 13485 status is a significant step forward, confirming that the robust quality management systems we have put in place are accepted by the world’s regulatory bodies.
“In addition to the groundbreaking technology behind IntelliCap, we have successfully demonstrated we have the right organizational infrastructure in place. This enables us to provide customers with a family of oral delivery products as well as an appropriate monitoring service, including the robust quality control systems needed to ensure adherence to strict regulatory compliance.”
And he continued: “Our customers see IntelliCap as one example of how we can provide an extremely powerful and comprehensive tool for the early-stage development of new drugs or for the life cycle management of existing drugs. Drug development is an extremely arduous, risky and costly process. IntelliCap has a significant role to play in helping direct future investment by providing speedy validation of a compound’s suitability for moving towards approval, or indicating its limitations.”
The technology behind IntelliCap is unique in the way it controls the release of a drug, giving precisely the right dosage, at the right place and time within the gastro-intestinal tract. Explaining why this is significant, Dr Weiner added: “This enables pharmaceutical researchers to tailor personalized delivery profiles, making it possible to interact in real time with the swallowed capsule. This is a significant improvement on existing wireless capsule systems, which allow only one pulse of drug release.”