KEMA is one of the largest Notified Bodies in the EU and FDA Third Party with full operational offices in California, Pennsylvania and The Netherlands. In addition, KEMA has a representative office in Munich, Germany and Tokyo, Japan. In 2006, KEMA started its own company KEMA Quality Israel, Ltd. near Tel Aviv to serve its growing medical client base in Israel.

Until 2006, MedicSense has been KEMA’s local sales representative. Now that KEMA has its own company and staff in Israel, KEMA has its own sales representation and MedicSense has become a consulting company that is well recommended by KEMA





The CE mark symbol on your product enables you to trade freely within the European Union. However, with this privilege come obligations. By affixing the CE Mark to your product, you are indicating your adherence to procedure compliance regarding in accordance to the relevant European Directives. In other words, you are responsible for the consequences of the use of your product. But how can you be absolutely certain that your product is in compliance with these Directives?

KEMA's expertise enables it to determine whether your product is in compliance according to the criteria of standards and European Directives. For most medical devices, this is mandatory. In such cases, KEMA acts as a Notified or Certification Body, and can perform all voluntary and obligatory tests and reviews of your product and organization. As a Notified Body, KEMA combines both the product testing and the system certification in a single audit, thereby saving you time and money!

Meeting CE Directives - KEMA knows the drill in Europe better than any other testing and certification institution due to both participation in standardization committees and having first-hand knowledge. And of course, KEMA is well known for its commitment to its clients, and has more than 75 years of experience in testing products. KEMA's outstanding reputation for efficiency, professional competence and on-time performance guarantees you the shortest and most efficient timeline from product development to reaching final market goals.

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 and CMDCAS audits. In addition, Kema is one of the few bodies worldwide to be included in the FDA third party program. The purpose of the FDA Third Party program is to provide manufacturers of eligible devices an alternative 510(k) review process that could yield more rapid marketing clearance decisions; and enable FDA to use its scientific review resources for higher-risk devices, while maintaining confidence in the review by third parties of low-to-moderate risk devices. The regulations for medical devices in the United States require the Food and Drug Administration (FDA) to inspect the manufacturer's facility at regular intervals. KEMA can do this on behalf of the FDA. KEMA is an accredited body for eligible QSIT inspections.

In order to prepare for Notified Body audits, prepare technical dossiers or 510(k) files, many companies obtain assistance from experienced QA/RA consultants. KEMA only recommends consultants that have the experience and competence to prepare companies for successful audits and file submissions. MedicSense is one of the experienced consulting companies in the medical field that is well recommended by KEMA. MedicSense’s years of experience in the field of medical devices compliance management - within both the EU and the FDA- combined with its knowledge and familiarity of the Israeli medical device industry enables it to provide flexible, customized services to its clients, thus guaranteeing their ability to take full advantage of all aspects of the European market.

KEMA's web site