IPB Inc. is an ISO 13485 certified company, and FDA registered for Medical Devices. We are also a BOMcheck registered company. IPB practices daily lean six sigma and has certified black belt six sigma staff to ensure continuous improvement.
Safety and quality are non-negotiables in the medical devices 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 best practice in everything they do.
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products.
Lean Six Sigma is a methodology that relies on a collaborative team effort to improve performance by systematically removing waste and reducing variation. It combines lean manufacturing/lean enterprise and Six Sigma to eliminate the eight kinds of waste (muda): Defects. Over-Production.
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.