Qualified & Certified

The objective of Rotem’s quality system is to continuously produce and supply high quality products that comply with relevant regulatory requirements while simultaneously meeting the requirements and expectations of customers. This is implemented by every member of the Rotem team, all of whom bear responsibility for placing quality at the top of their priorities.

Regulatory certifications enable users to rely on Rotem’s products when submitting their own filings (marketing authorizations, NDA’s, etc.) with their relevant authorities.  Rotem is certified as complying with the ICH Q7 Good Manufacturing Practice (GMP) Guidance for Active Pharmaceutical Ingredients, ISO 9001:2008 and ISO 13485:2003 standards.

Medical Imaging’s main quality principles are to:

  • Provide safe and effective products for customers, a safe working place for employees and effective production by controlling and documenting the entire production and control process.
  • Devote appropriate resources to enable manufacturing of quality products.
  • Strive for continuous improvement of products and processes while implementing a change control program to prevent unintended consequences of change
  • Where possible, prevent deviations and malfunctions and where not, report and correct the problem and assess potential effect on product
  • Work as a team with interdepartmental cooperation
  • Educate and train employees to ensure that company policy and work procedures are understood and to encourage active commitment to meeting the aforementioned goals
GMP
GMP Q7

Medical Imaging’s quality policy is based on its commitment to produce high quality products which is achieved by the implementation of the Q7 Good Manufacturing Practice (GMP) Guidance for Active Pharmaceutical Ingredients and ISO 9001:2000, ISO/IEC 17025 and ISO 13485:2003 standards.

certificate-4
EDQM

EDQM -European Directorate for the Quality of Medicines & Health Care.  Rotem is the only company currently listed in the EDQM website as holding a registered certificate for Mannose triflate

ISO 13485 logo
ISO13485

Medical Imaging’s quality policy is based on its commitment to produce high quality products which is achieved by the implementation of the Q7 Good Manufacturing Practice (GMP) Guidance for Active Pharmaceutical Ingredients and ISO 9001:2000, ISO/IEC 17025 and ISO 13485:2003 standards.

Standards_institute_of_israel_logo
ISO9001

Medical Imaging’s quality policy is based on its commitment to produce high quality products which is achieved by the implementation of the Q7 Good Manufacturing Practice (GMP) Guidance for Active Pharmaceutical Ingredients and ISO 9001:2000, ISO/IEC 17025 and ISO 13485:2003 standards.

Setting the Standard for cGMP PET Consumables