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Comprehensive Contract Manufacturing

Savyon Diagnostics has gained its reputation as a company specializing in development, manufacturing and marketing of in vitro diagnostics kits. These tests are based on various techniques (ELISA, MIF, IPA, Immunochromatographic rapid kits, DNA/RNA Micro Arrays and more). Savyon has been successful in establishing a world-wide network of over 80 distributors, spanning every continent support sales to medical laboratories, research establishments and clinicians.

 

Since its establishment in 1984, Savyon has accumulated extensive experience and broad know-how in developing, manufacturing and marketing kits; building upon our diverse experience in manufacturing, Savyon offers contract manufacturing and development services to different companies varying from startups to medium and large enterprises. We provide high quality products, efficient manufacturing schemes, regulatory affairs proficiency and dedicated personnel at all levels. Thus providing the highest level of competence in a cost effective manner.

 

As our skilled team of scientists developed and transferred to production a myriad of diagnostic tests over the past 25 years, we also offer assay development services, including, but not limited to assay development, prototype design, scale-up, SOPs and preparation of technical files for regulatory purposes.

 

Savyon is represented abroad by the European company, Obelis s.a. We are annually audited, both as a company and for each product that we produce by the Notified Body, mdc medical device certification GmbH. In addition, Savyon complies with:

  • The requirements for Medical Devices according to ISO 13485:2003
  • The Quality Management Standard SI ISO 9001:2008
  • The requirements of the Canadian Medical Devices Conformity Assessment System (CMDCAS)
  • The requisitions of the U.S Food and Drug Administration (FDA)

The perfect solution for your diagnostic and biotechnology production

 

Brochure

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