CE marking is a European system based on compliance of medical devices to regulatory requirements for maintenance of health, safety, effectiveness and performance, quality and the environment.
The CE mark on a medical device allows the medical device to be sold on the European market and in other markets that have adopted compliance to the EU requirements. In most cases, a CE mark application will be submitted by the legal manufacturer of the medical device.
Conceptual & detailed design including personnel/material flow diagram, pressure cascade, cleanness level, utilities and technology based on current GxP standards and common practices
An effective quality management system establishment, policies and SOPs writing, cultivation and manufacturing procedures, protocols and employees training
Utilities, systems, machinery and controls required for cultivation, development and manufacturing processes that will enable high quality, control and cost-effectiveness.
Cannabis products specifications and regulatory requirements completion including all relevant documentation and data in order to be submitted and sold in regulatory markets
New facility, infrastructure, utilities, system, machinery, software, control system, manufacturing/cleaning processes qualification and validation protocols, execution and reports
Guidelines for the process of cosmetics registration/submission in Israel The Department that is responsible to assure the safety and [...]
The medical and pharmaceutical industries are involved in new product development and manufacturing of medicines, medicinal products, biological products, [...]
1. Background Many biopharmaceutical and biological products are based on (different) cell-type fermentation. Biopharmaceutical products can be either intracellular [...]
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