IPB Inc. is an ISO 13485 certified company, and FDA registered for Medical Devices. We are also a BOMcheck registered company.
Safety and quality are non-negotiable in the medical device industry. Regulatory requirements are increasingly stringent throughout every step of a product's life cycle, including service and delivery. More and more, organizations in the industry are expected to demonstrate their quality management processes and ensure standards are upheld without compromise. ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally recognized standard that establishes the requirements for a Quality Management System specific to the Medical Device industry.
The US Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products and medical devices, as well as our nation's food supply and cosmetic products.
The Medical Device Single Audit Program, or MDSAP, is a unified protocol for registering products for sale simultaneously in the USA, Australia, Japan, Brazil and Canada. Adherence to this set of standards reflects quality without compromise. As our Quality System currently conforms to the standards, IPB elected to pursue full MDSAP certification with a globally respected notified body and received clearance in December 2020.
Products carrying a CE Mark have been certified for sale in the European Union and several other global markets. Along with FDA registration, the CE Mark is a universally respected certification that reflects the conformance of products and their manufacturers to a strict set of standards. As an indication of our commitment to quality and our growing international footprint, select IPB products are eligible to carry the CE Mark as of November 2020.
Founded in 1881, the Consumer Healthcare Products Association (CHPA) is the national trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. CHPA is committed to empowering self-care by preserving and expanding choice and availability of consumer healthcare products. As a member of CHPA, IPB has introduced several innovative Child-Resistant package designs to increase consumer safety and augment the availability of sensitive medicaments. IPB's C-R products all adhere to 16 CFR §1700.15 and have been certified by leading laboratories. Various patents pending.
As a certified and responsible medical device manufacturer, IPB is committed to protecting our interests and those of our customers and business partners. To provide added peace-of-mind, we carry substantial liability insurance provided by the globally-recognized firm, Hub International.
BOMcheck is an industry collaboration led by Philips, Siemens, GE, Osram, Sony Mobile, Schneider Electric, Toshiba, Agfa, Texas Instruments and TE Connectivity to share one web database to manage supply chain compliance. BOMcheck is highlighted in corporate videos produced by Siemens and Philips and is used thousands of companies to gather materials declarations for millions of parts. The system is supported by SGS which uses BOMcheck to provide EN 50581 RoHS compliance assessment services.