2020-08-06T17:41:30+00:00December 27th, 2018|

The development of medical equipment can be done in two ways: The first is the fast track route, which refers to the process of developing medical equipment that is already on the market, i.e., upgrading existing medical equipment. The second way is to develop new medical equipment from beginning to end. As with the development of any new product, even within the framework of medical device development, the process begins with the development of a prototype. Subsequently, various experiments and tests are performed to check the safety of the various devices and to obtain preliminary approval from the Ministry of Health to proceed. After this step, clinical research should be performed to evaluate the safety and efficacy of the medical devices in a representative group of patients. Upon completion of the clinical study and analysis of its results, applications may be made to obtain required regulatory approvals and, upon approval, the device marketing process may begin.

Product Development, Delivery System & Clinical Trials

Novel cannabis products and delivery system for improved bio-availability, accuracy, consistency and efficacy that can be proven and backed up with a strong IP and clinical trials

Growing, Manufacturing & Lab Facilities Design

Conceptual & detailed design including personnel/material flow diagram, pressure cascade, cleanness level, utilities and technology based on current GxP standards and common practices

Quality Assurance & Good Practices (GxP)

An effective quality management system establishment, policies and SOPs writing, cultivation and manufacturing procedures, protocols and employees training

Cultivation & Product Manufacturing Technology

Utilities, systems, machinery and controls required for cultivation, development and manufacturing processes that will enable high quality, control and cost-effectiveness.

New Product Regulations & Submissions

Cannabis products specifications and regulatory requirements completion including all relevant documentation and data in order to be submitted and sold in regulatory markets

Qualification &Validation

New facility, infrastructure, utilities, system, machinery, software, control system, manufacturing/cleaning processes qualification and validation protocols, execution and reports

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