Omnia Quality

At Omnia, we focus on achieving the highest level of reliability and quality in our products to ensure the safety of both patients and surgical staff.
We carry on a continuous research to provide a product that is constantly evolving, keeping pace with recent advances in technology and international standards.

Medical devices manufactured and marketed by Omnia must:

Meet the expectations of medical practitioners in terms of adequacy, safety, ease of use and clinical reliability

Be in line with the most advanced security and usability parameters, as required by the FDA cGMP 21 CFR for medical devices

Be produced and sterilized according to validated and controlled methods

Omnia Quality Rulebook

Our products comply with National and International quality standards and meet the requirements of the FDA cGMP 21 CFR requirements for medical devices, the Canadian medical device regulation CMDR SOR/98-282, and of the Medical Devices Directive 93/42/CEE, as amended by the Directive 2007/47/CE

Our quality system is designed in accordance with the requirements of the UNI CEI EN ISO 13485 standard in order to activate appropriate preventive actions to minimize product defects and to avoid the marketing of non-conforming devices

All personnel are all well trained, actively participate in company activities and are involved in problem-solving and innovation projects aimed at improving the quality of all products and services

We constantly monitor post-market activities to ensure the continuous improvement of our products in terms of safety and suitability for use

We evaluate any complaint or non-compliance to further our professional growth and continuous improvement of our service and our quality system management

Our labels and usage instructions reflect the product descriptions and intended uses for which they were designed

During the internal manufacturing phase, monitoring is direct and constant in order to guarantee ever-increasing quality and safety standards

We guarantee the traceability of all materials and components used in the production of our products as well as the processes used to arrive at the final product delivered to the customer

Our suppliers work in compliance with the regulations surrounding the products they supply. They are qualified and their degree of reliability is monitored

Corporate, human and technological resources are utilized to develop new products as well as the continuous improvement of Omnia’s current offerings

Certifications

To ensure excellent quality, we continue to achieve company and product quality certifications.
All of the latest certificates are available here

Production

Our production department is made up of an “ISO CLASS 8” white room and warehouse, which allows optimal creation and delivery of custom products. Our production system is called “room in room”, with access to the clean room only through decontamination chambers. This system is controlled by the multitude of safety and security checks and balances that need to be satisfied. Clean room air quality is of the utmost importance for the production and packing of aseptic medical components. Filtration, air conditioning, and diffusion systems are needed to protect against bacteria, dust and harmful substances.

Materials

Our medical grade, high-performance materials comply with industry standards and regulations. All materials are DEHP and Latex free, unless otherwise indicated on the packaging. Our products are packed with sterile packaging: a medical blister and an outer box in order to guarantee absolute safety during the opening stage, and they are then placed in specific shipping cartons. The TNT material, designed and developed to enhance comfort and safety during dental procedures, ensures maximum hygiene, care and protection for operators and patients. The minimum thickness makes the products soft and comfortable, while ensuring an excellent barrier effect. The non-toxic and medical grade PVC material ensures safety and hygiene without compromising the functionality of the equipment on which it is being used. In our packaging we only use high quality materials, paying close attention to the various packing, storage and shipping procedures.

Planning

Planning is one of the strengths of our quality system. Some medical devices such as procedure sets and irrigation lines can be designed and customized based on the customers’ needs. This process has enabled us to reach a high level of know-how in the production of products designed for use with specific surgical instruments and for surgical procedures.

Traceability

The traceability of our medical devices is guaranteed from the components and raw materials used. Coding and parceling systems, along with the date of production and expiration, allow us to trace a medical device from its origin to its final use. In addition, we are implementing the Unique Device Identification (UDI) coding system which identifies the manufacturer, model and lot number of a medical device and allows us to trace it throughout its lifecycle.