Per- and polyfluoroalkyl substances (PFAS) have become a growing concern in the medical industry due to their potential negative impact on patient safety and environmental sustainability. Consequently, regulatory authorities and healthcare organizations are more vigilant about reducing or eliminating PFAS from medical devices to enhance patient safety and protect the environment.
Medical device OEMs face several obstacles in addressing PFAS-related concerns:
- Compliance and Regulations: Keeping up with the evolving regulatory landscape regarding the use of PFAS in medical devices can be daunting. Non-compliance could lead to severe consequences, including product recalls and legal issues.
- Material Substitution: Finding suitable alternatives to PFAS that maintain the same level of performance and safety in medical devices requires extensive research and development.
- Environmental Sustainability: Ensuring that medical devices are environmentally sustainable, from sourcing materials to end-of-life disposal, is a critical consideration for OEMs. At LTTS, our extensive experience with regulations such as RoHS/REACH positions us well to support and collaborate with medical devices OEMs.
Our team of specialists help in:
- evaluating and converting/upgrading products to comply with the latest EU Regulations
- conducting BOM scrub and gap analysis followed by compliance information gathering (CoC)
- identifying drop-in replacement for non-compliant/EOL parts
- alternate solutions and impact analysis
- testing support
Together, we can create a safer and healthier healthcare for patients and the planet.
Download to learn more about how you can drive your medical devices toward a brighter and sustainable future.
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