Simplifying the complex world of medical device compliance requires a trusted partner with unparalleled expertise. Arra Lore is committed to helping you bring innovative and high-quality medical devices to market efficiently and confidently.
We offer comprehensive medical device assurance, testing and certification solutions designed to meet stringent regulatory requirements, including FDA guidance, 60601-1 standards, and other global standards. Our services ensure your devices not only comply with the latest safety and performance regulations but also gain faster market entry to every region around the world.
From electrical safety and EMC to cybersecurity, biocompatibility and beyond, our experts are well-versed in the challenges of today’s medical device regulatory and compliance landscape. Whether you’re developing never-before-seen technologies or improving existing FDA-approved medical devices, Arra Lore provides the assurance you need to succeed.
** The Arra Lore legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Arra Lore legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Arra Lore.