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Medical Device Technology, the current exhibition at Birmingham's NEC, is drawing specialist buyers from all over the world. Attracting a great deal of attention at the show is the display mounted by Meddiquest Ltd of Stevenage.
MeddiQuest is a regulatory affairs management company specializing in finding simple and effective strategies to bring novel and hi-tech healthcare products to market. "We support our customers with regulatory, management and market expertise and training/coaching programmes for their own employees," says managing director, Neil Armstrong.
"Our own international experience, coupled with local strategic partners, enables us to offer a full worldwide service for researching, registering and importing healthcare products to any market.
"Our multidisciplinary team is focused on our customers' needs and our local partners are always happy to conduct whatever 'in-country' services are required. We deal with everything to speed your new products to market!"
MeddiQuest has formed a strategic alliance with Latini & Associados in São Paulo, Brazil. Neil Armstrong, managing director of MeddiQuest, said: "This will enable us to offer a full regulatory affairs service for all South America, not just Brazil. We see huge benefits in having a trusted local partner who can represent the interests of our customers to government. The arrangement provides a major advantage for companies trying to enter this market.
"This will be a key relationship in developing the 'MeddiQuest Network' which includes partners in China, Eastern Europe, Japan, the Middle East and the U.S.A.
The MeddiQuest Network also includes communication, management development, funding and project management experts to help clinicians, scientists and engineers grow into managers and directors.
MeddiQuest actively supports the Cambodia Trust that runs many self-help initiatives to manufacture artificial limbs for land mine victims in Cambodia.
While visiting South America and setting up strategic partnerships, Neil Armstrong also spoke at the annual conference of the ABPVS (Associação Brasileria dos Profissionais em Vigilância Sanitária), a key organization in influencing government regulation of the healthcare sector on CE Marking of medical devices and the EU experience.
As well as being MeddiQuest's managing director, Neil Armstrong has been on the RAPS (US Regulatory Affairs Professionals Society) Ethics Task Force, is Chair of the IQA (Institute of Quality Assurance) Medical Device Quality Group and on the strategic planning committee for RAPS in Europe.
MeddiQuest has also been busy adding partners within the UK to ensure that they can offer an integrated single-source solution for turning a great idea into a marketable medical device. Neil Armstrong says: "Modern Business is all about people - tasks need to happen concurrently and regulatory affairs is a natural co-ordinating function. Through our network of scientists, designers, market researchers and clinical experts, we can bring together a project team who we know share core values and appreciate the others needs."
The US FDA (Food and Drug Administration) granted Sea-Band Ltd., Hinckley, Leicestershire, clearance to market their 'Sea-Band'(r) acupressure wrist bands as an over the counter medical device. This completed two years of co-operative work between FDA, MeddiQuest and Sea-Band.
When the Sea-Bands were first marketed in the United States, FDA did not accept acupuncture, let alone acupressure, as a medical technique. With the landmark clearance of the 'Sea-Band' FDA has created a new product code for acupressure devices, and cleared the 'Sea-band' for use to relieve nausea, whatever the cause, travel-sickness, morning-sickness, post-operative sickness and post-chemotherapy-sickness.
"A simple non-drug device that can significantly affect the quality of life of ordinary people has come of age," says Neil Armstrong.
MeddiQuest has recently become a distributor for the Tarius Legal and Regulatory Database. Neil Armstrong says: "Tarius has long been an exciting product for the pharmaceutical industry providing all US and EU law and regulations in an easily searchable and annotatable form, and the inclusion of medical devices, later this year, will truly make an indispensable product for all involved with healthcare Regulation."
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