Manage Regulatory Compliance and Reduce Product Risk

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.
Read expert perspectives on Conflict Materials at our resource center.

UDI Compliance

Compliance with new U.S. FDA requirements for UDI (Unique Device Identification)

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.
Take a deeper view into the challenges, cost and advantages of UDI compliance.

ISO 26262 | Functional Safety Standard for Road Vehicles

ISO 26262 - Functional safety standard for road vehicles

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.
Learn the best ways to comply with this automotive regulation.