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KEMA steps up activities in Israel
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An increasing number of Israeli medical device manufactures call in KEMA to gain access to the European, US and Canadian market. To simplify communication with the client and to be able to perform its auditing and product review work with local personnel, KEMA will open a local office in Israel. MedicSense will act as its representative.
Israel has a well-earned reputation for technological innovation, especially in the field of medical devices. To gain access to the European market, these medical devices have to meet the CE and ISO 13485 standards. Over the years KEMA has offered certification services to manufactures. Today its clientele includes some forty medical device companies that are being served on a continuous basis.
This has led to the strategic decision to open a local KEMA office in Israel. This office will focus fully on increasing the medical device business. To this end, an agent contract has been signed with the local company Medicsense. MedicSense will represent KEMA and perform sales activities.
Local presence
KEMA’s decision is based on the desire to simplify the contact with its customers. In addition, it wants to perform part of its auditing and product review work with local personnel. Depending on results in the first year, the idea is to expand this activity to a full-scale operation in the future.
To launch KEMA’s presence, a seminar has been scheduled for the medical device community in Tel Aviv on April 18, 2005.
Notified Body
KEMA is one of the larger Notified Bodies in the EU for the Medical Device Directive, the Active Implantable Medical Device Directive and the In Vitro Diagnostic Directive. KEMA has also been recognized for conducting ISO 13485 audits.
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