Sustainable Packaging! 

Sustainable Packaging with bioplastics for Medical, Cosmetic Packaging, Hygiene, & Food Contact applications.  

Bioplastics to meet your sustainability initiatives!

Circular Bio- Economy

Modular Bioplastics to meet your mechanical & technical properties!

Sustainable Packaging

Highest Quality Medical Grade Bioplastics

Medical, Hygiene, & Food

Rigorous ISO 10993 & ISO 13485 compliance.

FAQ

What is ISO 13485 medical grade bioplastic?

ISO 13485 is a quality management standard specifically designed for medical devices. It provides a framework for ensuring that medical devices are produced consistently and meet regulatory requirements. The standard specifies the requirements for a quality management system that can be used by medical device manufacturers, suppliers, and other organizations involved in the medical device industry.

ISO 13485 certification is a process by which an organization demonstrates that it has implemented an effective quality management system that meets the requirements of the standard. The certification process involves an audit by an independent certification body to verify that the organization’s quality management system meets the requirements of the standard. Once certified, the organization can display the ISO 13485 certification mark to demonstrate its commitment to quality and compliance with industry regulations.

In summary, ISO 13485 certification is a mark of quality and compliance for organizations involved in the medical device industry, indicating that they have implemented an effective quality management system that meets the requirements of the standard.

What is ISO 10993 medical grade standard?

ISO 10993 is a set of standards developed by the International Organization for Standardization (ISO) that provides guidelines for the biological evaluation of medical devices. The ISO 10993 standard series is intended to assess the potential risk of biological hazards associated with the use of medical devices on patients.

ISO 10993 certification is a process by which medical device manufacturers and suppliers can demonstrate that their products comply with the ISO 10993 series of standards. The certification process involves evaluating the biological safety of a medical device, which includes identifying any potential hazards and assessing the level of risk associated with the use of the device.

The ISO 10993 certification process typically involves a series of tests, which may include in vitro tests, in vivo tests, and/or chemical analysis. These tests are designed to evaluate the biocompatibility of a medical device, including its potential to cause irritation, inflammation, or toxic reactions in patients.

Once a medical device has been certified to ISO 10993, it can be marketed as safe and biocompatible, which can help to increase patient confidence in the device and improve its marketability.

In summary, ISO 10993 certification is a mark of compliance with a set of standards that provide guidelines for the biological evaluation of medical devices. It demonstrates that a medical device has been evaluated for its biological safety and found to be compliant with industry standards.

What is the timeline for evaluations ?

Timelines vary depending on the complexity of compounds and transit times.

What is the shipping timelines after final approvals?

We work with your logistics teams to insure automated shipping and billing.  Initial order is 6-10 weeks for delivery from your final approvals. 

How do we begin working on a project?

We provide all levels of support and documentation to help with your transition to bioplastics. Review our Feasibility Package, Prototype Package, and Innovator’s Package to begin working on your specific needs.  

How can I sample the bioplastics

We have several sample options available depending on the products Sample and trial programs available from 360bioplastics are engineered to meet your circular bio-economy standards.  

What are the cost of evaluating?

Let’s schedule a time to discuss your requirements to determine your options. 

How can we help with your sustainable packaging?

Biomaterial Engineering Consulting!

Help Protect our Planet

Schedule a free consultaiton 

Convert your plastic products to water, carbon, or carbon dioxide

We have the expertise! 

Clean. Sustainable. Efficient.

ISO assurances to meet your sustainability objectives. 

 

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