Create high quality products and comply with global regulations
Leading manufacturers face ever increasing challenges to bring new products to market that adhere to regulatory compliance mandates around the world. Without clear visibility into regulatory requirements and their impact on product design and development, manufacturers can be put at risk of being late to the market or suffer the effects of product recalls. Compounding this challenge is the growing complexity brought on by the increased number of product variants to meet local and regional customer requirements.
Understanding the scope and the impact of regulatory requirements from every country the product can be bought, and how they affect your products and your product development process can determine market success or failure. By managing your product’s regulatory compliance and associated risks in the earliest phases of development, where decisions have the most impact and are least disruptive, better performing, compliant, and more profitable products can get to market faster.
Address critical requirements of the U.S. Securities and Exchange Commission (SEC) on Conflict Minerals
Beginning May 31, 2014 companies listed on the U.S. stock market, as well as, companies conducting business with US traded companies will have to make their first disclosure on whether materials they use are “conflict free”. This discloser poses huge financial and process implications for companies throughout the globe.
Although the new FDA requirements on the surface seem only to serve to provide UDI-compliant labeling, a huge challenge lies with the vast amount of data that needs to be handled for compliant submissions for each product. These include product versions, variants, configurations and packaging.
In November 2011, the new automotive standard ISO 26262 gave all manufacturers a common means to measure and document the safety of an automotive system while it is in service. Created specifically for production automobiles, ISO 26262 provides a series of steps to manage functional safety and to regulate product development on a system, hardware, and software level throughout the entire product lifecycle – from concept development through decommissioning.
Regulatory Explosion demands product development changes to ensure compliance and reduce product risk
Global manufacturers must keep pace with a growing regulatory environment across all regions. Keeping pace with regulatory requirements and ensuring corporate compliance impacts Product Development, from design to manufacturing to supply chain. Engineering leaders must account for continuous change in order to manage product and company risk.
Schneider Electric, global leader in energy management, achieves business value through their successful compliance strategy.