2020-08-04T11:46:46+00:00March 8th, 2020|

A harmonized, global definition of “medical device” (MD) does not yet exist.

US law and regulations define a medical device as “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent…intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or Intended to affect the structure or any function of the body…and which does not achieve its primary intended purposes through chemical action …and which is not dependent upon being metabolized for the achievement of its primary intended purposes…”

EU law and regulations define a medical device as any “instrument, apparatus, appliance, software, material or other article… for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease,…injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means…”

The different heath authorities have rules for determining the risk class of a medical device, based on its potential for harm if misused, design complexity, and use characteristics. Risk classifications generally range from Class I through Class III or IV, where Class I is the lowest level of risk. Risk classification has an impact on the regulatory pathway to be followed for product registration applications and may also influence the quantity and quality of documentation required to support the applications in each target market.

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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