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Software as a Medical Device

SaMD - ISO 13485, IEC62304, ISO14971, 510K SUPPORT

COMPLIANCE AND QUALITY AS STANDARD

In order to properly commercialize a software as a medical device application having the right partner who understands how to bring together good software development lifecycle practices, your regulatory profile, and the risks associated with your proposed device is absolutely vital. 

At CompliancePath we specialize in making sure that the inflection point where compliance meets quality is always at the heart of our project delivery. Far too many great ideas never make it to market because the foundational steps necessary to achieve regulatory compliance and a successful device approval are often considered too late.

COMMERCIALIZATION AND STRATEGY

CompliancePath will lead the way as you and your team begin your journey.

Together we can create and develop a successful commercialization and regulatory strategy for your device.

  • Developing an ISO13485/ISO14971 centric quality system
  • Establishing an IEC62304 compliant SDLC
  • Working together to achieve commercialization