Designing Medical Products for RoHS, REACH and Global Hazardous
Substance Regulations

Retooling legacy products and information systems to eliminate toxic substances while maintainingproduct quality and supply chain continuity.

Medical device manufacturers are no longer exempt from key international environmental regulations such as REACH and RoHS. This means they must exclude certain substances from their products, and keep track of others that could be banned in the future. They must understand and control their supply chains, and collaborate with their suppliers and customers, to an extent never required before. But with this challenge comes an opportunity. Firms can use the compliance process to transform their supply chains, achieve a better understanding of their products and processes, and redesign outdated products.

The following topics are covered in the paper:

• An overview of the environmental regulations that are driving change.
• Discussion of how these issues impact the medical device industry.
• Strategies for gathering the needed information and using it to update your products and processes.
• An analysis of electronic systems for keeping up with regulations and standards, and their role in supply chain transformation.
• A guide to the steps firms should take when embarking on restructuring the supply chain.

This paper will help design and sourcing professionals make sound decisions with awareness of the scope of current and pending regulations, the direct relevance to their business practices, and the critical steps they can take to improve their business processes and profitability.