Medimetrics Confirms Capability for Design and Delivery of Medical Devices and Related Services by Gaining ISO 13485 Certification
6/25/2013 9:59:48 AM
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EINDHOVEN, The Netherlands, (21 March 2012) -- Biotech innovator Medimetrics confirms it is on track with its strategy to become a global provider of oral delivery medical devices and related services by gaining vital ISO 13485* approval. 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.”
Medimetrics was originally formed by Philips in 2008 as a research company to develop IntelliCap. The expanding market has seen the emergence of Medimetrics Personalized Drug Delivery B.V. as a fully- fledged biotech company in its own right. The new entity, a Philips-associated company, has won substantial backing from Germany-based Zukunftsfonds** Heilbronn GmbH & Co KG.
Medimetrics has its headquarters in Heilbronn, Germany, with research labs, service centres and administrative offices in both Europe (Eindhoven, The Netherlands) and the USA (Briarcliff Manor, New York). For further information, visit www.medimetrics.com
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