Our Certifications

We are proud to be working with an outstanding webbing supplier who is well known for outstanding ISO medical materials. ISO 13485 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings. ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing of medical devices and calls for:
Implementation of a Quality Management System with several enhancements
Risk Management approach to product development and product realization
Validation of processes
Compliance with statutory and regulatory requirements
Effective product traceability and recall systems

This standard allows companies to reduce safety and legal risks while creating more economical work environments. As an internationally recognized standard of quality and safety for medical device manufacturing, having ISO 13485 certification helps companies get recognized as more reputable, trustworthy providers. The most recent version of ISO 13485 is reviewed every five years and revised according to the new requirements and needs of the industry.

IMO Certification

We joined Shopify Planet shipping carbon neutral. Every time an order is processed and shipped, a small contribution is made to purchase carbon removal credits from companies that are a part of the Shopify Sustainability Fund, creating technologies and solutions that pull carbon dioxide out of the atmosphere and store it long term. Each company Shopify chose to support is working toward a shared goal of finding innovative ways to create a more sustainable future. They’ve all created solutions that could truly revolutionize their sector and make an impactful contribution to reversing climate change at scale. 

 

Pelvic Pain Solutions' foam supplier is CertiPUR-US. Together, we are committed to providing you with the purest and healthiest seat cushions on the market, while maintaining environmentally conscious, ethical and sustainable business practices, to help safeguard your health and protect our planet. In order to achieve this, we ensure that our products and our business meet the highest standards of the most rigorous tests and organic certifications in the industry.

Our super cleanable fabric supplier for our seat cushions is child safety compliant. CPSIA confirms products meet a range of safety specifications, and requires mandatory third party testing for all children’s products. Proposition 65 sets out specific requirements regarding the toxicity of materials used in products that are to be sold in the State of California, including textiles, hard goods, toys, juvenile products, and electrical and electronic items.

Our supplier is RoHS compliant

Our super cleanable fabric supplier for our seat cushions is child safety compliant. RoHS, which stands for Restriction of Hazardous Substances, is a directive established by the European Union (EU) to regulate the use of certain hazardous materials in electrical and electronic equipment. When a product is described as "RoHS compliant," it means that the product meets the requirements outlined in the RoHS directive, and it does not contain certain restricted substances beyond specified limits.