Download our exclusive white paper 

White Paper: Are We Equipped to Handle a PFAS-Free Future?

In an era where sustainability meets innovation, the medical device, and in vitro diagnostics (IVDs) industry faces one of its most significant challenges yet: transitioning away from per- and poly-fluoroalkyl substances (PFAS). With approximately 15,000 chemicals in the PFAS family affecting everything from material sourcing to product design and regulatory compliance, the question looms large—Are we equipped to handle a PFAS-free future?

Unveiling Insights by Dr. Jaishankar Kutty

RQM+ proudly presents a comprehensive white paper by Dr. Jaishankar Kutty, a leading voice in the field, addressing the impending supply chain and regulatory issues associated with PFAS phase-out. Dive into an in-depth analysis covering:

• The critical role of PFAS in medical device manufacturing
• The impact of regulatory changes and supply chain disruptions
• Strategic approaches for a smooth transition to PFAS-free alternatives

Why This White paper Is a Must-Read:

• Regulatory Insight: Understand the implications of the EU's proposed REACH restriction and the US's regulatory landscape.
• Supply Chain Strategies: Explore solutions for the imminent challenges posed by major suppliers like 3M discontinuing their PFAS portfolio.
• Innovation and Safety: Learn about alternative materials that maintain the integrity, safety, and performance of medical devices.

The journey towards a PFAS-free future is complex but navigable with the right knowledge and strategies. Fill out the form on this page to access this essential white paper and equip your team with the insights needed for a seamless transition.

MEET THE AUTHOR: 

Dr. Jaishankar Kutty, Vice President, Global Regulatory Affairs at RQM+

Jaishankar is an eclectic combination of significant EU notified body experience (as a lead technical and clinical reviewer at BSI) and practical industry experience in design and development of cardiovascular devices. Currently, he is focused on assisting medical device manufacturers, in a clinical-regulatory strategic leadership role at RQM+.

He helps the RQM+ team find practical solutions in all areas of clinical evidence, biological safety, and EU regulatory strategy. His core competencies span medical device design, pre-clinical model development and biological safety evaluations, advanced biomechanical testing, biomaterial science and chemical characterization, cell biology and tissue engineering, and clinical evidence synthesis and analysis.