Greatbatch's (GB) Electrochem division, which offers high performance commercial batteries, has concluded its ISO 13485:2003 registration audit. The audit is carried out by the National Standards Authority of Ireland. In addition, the company’s division has received a recommendation for certification. Electrochem anticipates receipt of final certification in about one and a half months time.
The ISO 13485:2003 certification spells out mechanisms for a company’s quality management setup to exhibit the capability of producing medical devices that satisfy client and regulatory requirements regarding standards concerning medical device application.
Electrochem focuses on technology offerings for critical situations, where failure is not at all tolerable. The above-mentioned certification, in conjunction with its recent takeover of Micro Power Electronics (an ISO 13485:2003 certified enterprise), gives a proof of Electrochem’s long-standing commitment to mobile medical gadgetry.
Greatbatch is a leading producer and supplier of batteries, capacitors and components used in implantable medical devices. The company’s top customers include Boston Scientific (BSX”>BSX), Johnson & Johnson (JNJ”>JNJ), Medtronic (MDT) and St. Jude (STJ”>STJ).
Greatbatch’s smaller Electrochem division manufactures high performance batteries for use in oil and gas exploration, oceanographic equipment, seismic surveying equipment and aerospace. The division accounted for roughly 14% of the company’s sales in 2010.
Greatbatch has been acquiring complementary businesses over the last few years to boost sales. The company’s pipeline is healthy with a number of products currently under development that are expected to support growth in the long run. Moreover, Greatbatch continues to invest in developing medical devices for its major OEM clients.
We believe that the operating results will be backed by the company’s strength in its orthopedic business and strategic investments. Moreover, synergies from cost-cutting and restructuring initiatives are expected to support margin expansion. Currently, we have an Outperform recommendation on Greatbatch.
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