What is a quality system in the medical field?

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What is a quality system in the medical field?

2020-08-04T15:34:30+00:00December 27th, 2018|

A quality system in the medical field is designed to ensure the safety, efficacy and quality of a consumer medical product and has the aim of protecting public and patient health. Quality managers in development and/or at manufacturing companies must have the appropriate education and experience, while being familiar with specific, relevant standards and regulations.

To the article Quality Assurance Systems and CAPA

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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