Siemens Pacesetter gains ISO 9001 approval for cardiac devices – Siemens Pacesetter Inc
Siemens Pacesetter, Inc., Sylmar, Calif., expects its recently awarded ISO 9001 certification to slightly increase U.S. sales of the company’s implantable devices for cardiac rhythm management, even though the certification is primarily intended to boost foreign sales.
Siemens officials slightly altered the company’s manufacturing process to meet certification criteria, which Siemens officials expect will greatly boost foreign sales by surpassing the government standards required to sell products in those countries. In the United States, the revised designs will allow the company to market the equipment as improved products.
The certification follows a successful review and audit by an inspection team from Munich, Germany-based TUV Products Services, an accredited auditing agency of the European Community (EC). The standards by which Siemens was judged were developed by the International Organization for Standardization in Geneva, Switzerland.
The company’s adherence to the standards makes Siemens eligible to apply the CE mark to its products. The mark is recognized around the world, including the EC, which will use the mark as a requirement for companies marketing active implantable medical devices within the EC by 1995.
The effects of the certification in the United States will be less tangible because Siemens products already meet Food & Drug Administration requirements.
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