Manufacturing Crisis and Rapid Response for Medical Devices

Product contamination and product failure investigation can mean many things to many people.

• For a Research Scientist it can mean unexpected levels of leachable materials diffusing from a newly formulated device or packaging.
• For a Manufacturing Engineer it can mean unexpected production downtime.
• For a Production Manager it can mean reduced product yields.
• For a Quality Manager it can mean investigations reportable to the FDA.
• For a Business it can result in exceptional costs, product recalls and damage to reputation.

A huge variety of contamination outbreaks can occur, from particles and fibers to traces of heavy metals and parts per billion of leachable organic components. Product fracture and failure investigations can arise during manufacturing, as a result of product shipping and even from the end user procedure itself.

Intertek scientists have a strong track record in quickly and effectively managing contamination and product failure outbreaks. We personally guide you through the myriad of analytical technologies available. Our aim is to fully characterise the contaminant qualitatively and quantitatively where necessary. We also help determine the cause of product defects, fractures and failures while working closely with you to quickly control, define the root cause and eliminate the problem.

Efficient and effective Contamination and Product Failure investigation is a prerequisite to solving a manufacturing crisis but at Intertek we go much further.

• With laboratories all over the world we have someone on hand close to you.
• We are well aware of the technologies involved in the crucial raw material supply chains of metals, polymers and active pharmaceutical ingredients.
• We help you understand how best to collect and package samples of in process materials for detailed scientific investigation.
• We extend your local problem-solving capability by having corrosion scientists, metallurgists, polymer scientists and pharmaceutical specialists on call.
• We guide you through what can be a stressful time. Working in partnership with your engineers, scientists and management we form teams quickly to help you immediately understand the issue in hand and the global capabilities Intertek can bring to bear to solve the crisis quickly and efficiently.
• Quite apart from providing scientific support to a manufacturing crisis - Intertek also provides managers with an independent understanding of the potential regulatory issues involved, access to global risk assessment specialists and we can help you understand how best to handle product recalls.
• We cover major time zones through the two phone numbers and e-mail addresses above - so at any point in time you are only one step away from a helping hand when you most need it.

Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.