Fischer Imaging is on the verge of being certified to the ISO9000 standard, a quality standard that began in Europe but israpidly gaining worldwide recognition as an indicator of quality. The Denver-based company passed inspection by a European
Fischer Imaging is on the verge of being certified to the ISO9000 standard, a quality standard that began in Europe but israpidly gaining worldwide recognition as an indicator of quality.
The Denver-based company passed inspection by a European registrarthe week of Aug. 16, according to James Morgan, director of regulatoryaffairs and quality assurance.
"For all intents and purposes, we are certified,"Morgan said. "We just can't say it officially."
Fischer should receive official notification in mid-October,when the paperwork is completed by the European registrar, DetNorski Veritas, which maintains a U.S. office in Houston.
The impetus to be registered to the standard came from VarianOncology Systems in Crawley, U.K. The English company, which buysgenerators from Fischer for its radiotherapy equipment, has tobe registered and requires the same of its suppliers. But ISOcertification would probably have been pursued regardless of Varian'srequests, according to Morgan.
"ISO 9000 is becoming the world standard for businesssystems," he said.
About 55 countries, including many outside Europe, such asJapan and Canada, have adopted it. ISO 9000 is not itself a qualitysystem, Morgan noted. Rather, it documents that such a systemis in place at a company.
To manage quality, Fischer relies on a total quality managementsystem, which has been in place for the last four years.
"ISO 9000 certification demonstrates to people on theoutside that there is a commitment here to wanting to do thingsright, and that the programs are in place to do them right,"Morgan said.
Burlington will provide an update on the device product approvalprocess and personnel and organizational changes at CDRH. Alsoappearing will be Ronald Johnson, director of the CDRH's officeof compliance. Johnson will discuss good manufacturing practices(GMPs) and other postmarket activities.
Viewers will be able to participate in the discussion by telephoningor faxing questions to Burlington and Johnson. For informationabout how to participate in the teleconference, contact the program'ssponsor, the Food and Drug Law Institute, at 202/371-1420.
The conferences will be held quarterly, according to the FDA.
According to the study, the total annual operating cost ofa cyclotron-based clinical PET facility is $1.87 million, comparedto $1.62 million for an accelerator-based center.
To avoid reimbursement costs rising to unacceptable levelsas PET use grows, the study recommends that Medicare reimbursementbe based on efficient utilization of PET scanners. The ICP suggeststhat a scanner facility is efficiently utilized if its PET camerais being used 75% of the time it is available.
The study is available by contacting the Institute for ClinicalPET at 703/516-9255.
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