A Medical Device Daily
SterlingTech Software (Rochester Park, New Jersey), a provider of custom software solutions for the medical device industry, said it has received a grant from the State of New Jersey to pursue ISO 9001 certification.
The company also said that John Campbell, director of quality assurance, has moved to its corporate headquarters and technology center in Rochester Park to oversee the certification process.
As part of the validation process, SterlingTech said it also would be applying for ISO 13485 certification, a medical device-specific subset of ISO 9001.
“The most vital aspect of any medical device development company is its quality system,” Campbell said. “ISO certification represents the next logical step in SterlingTech’s growth. It provides another level of assurance to new and existing clients that the work we do adheres to the stringent guidelines set forth by the International Standards Organization.”
Campbell brings more than 30 years of experience to the certification process, the company said. Before joining SterlingTech, he served as director of engineering for Sulzer Intermedics. Prior to that, he was manager of quality assurance for Texas Instruments.
“In addition to validating SterlingTech’s quality system and practices across the board, ISO certification will allow our customers to streamline their auditing processes when selecting a medical device development partner,” said Dan Sterling, SterlingTech’s president. “And I’m thrilled that a man with John Campbell’s medical device expertise and experience will be overseeing this important project.”
SterlingTech provides software development, testing and validation services exclusively for the medical device industry.
In contract news:
NetJets Europe (London), a private jet company in Europe, said it has renewed its contract for another three years with aviation medical specialists MedAire (Tempe, Arizona).
Through 2010, NetJets Europe crewmembers will receive MedAire’s medical training, onboard medical kits, and remote telemedicine expertise, ensuring NetJets will continue to be well prepared to handle any medical situation, according to the companies.
MedAire will continue to provide various services to NetJets Europe, including MedLink telemedicine response center, providing NetJets crew with immediate access to emergency doctors during in-flight medical emergencies; MedLink WorldWide ID cards for all NetJets Europe owners, giving them MedLink access any time they are traveling or away from home; management of in-flight illness and injury training, covering common in-flight illness, altitude physiology, equipment, oxygen systems and CPR/AED instruction.
It also will provide one aircraft first aid kit per aircraft, engineered to help operators deal with medical situations that commonly occur in the aviation environment. That service includes kit refurbishment and content replenishment for more than 500 kits over the course of three years; one Emergency Medical Kit per aircraft, designed for long-range aircraft to treat serious or complex conditions ranging from chest pains and severe allergic reactions to gastrointestinal problems and asthma attacks. It also includes refurbishment and content replenishment.
Cigna HealthCare (Bloomfield, Connecticut) reported the signing of a multi-year contract with Northeast Georgia Health System (NGHS) and Northeast Georgia Primary Care (both Gainesville, Georgia). The new contract, continuing a longstanding relationship between the organizations, allows individuals covered by Cigna HealthCare to continue to receive in-network care at NGHS and the Northeast Georgia Primary Care facilities.
Cigna HealthCare provides medical benefits plans, dental coverage, behavioral health coverage, pharmacy benefits and products and services that integrate and analyze information to support consumerism and health advocacy.
NGHS is a not-for-profit community health system that offers a full range of healthcare services through two hospital campuses. Northeast Georgia Primary Care, an affiliate of NGHS, has primary care centers located throughout northeast Georgia. The centers are staffed with family physicians, internists, nurse practitioners, physician assistants and other healthcare providers.