SaMD Regulations and Compliant Development Environments

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When time and resources are limited by daily demands and execution, it can be difficult to focus on building your IT strategy.

Our products allow you to focus on innovating. We can help you implement a GxP-compliant framework for every layer of your tech stack and maintain your validation.

A unified IT strategy enhances your speed to market.

With a carefully planned IT roadmap, your early-stage company can gain a competitive advantage and improve business outcomes.

Our expertise spans every phase of the validation process, from identifying and analyzing gaps to developing your IT strategy and roadmap. We have experience in implementing GxP best practices and selecting the right technology vendors to ensure you are in continuous compliance.

As your business grows, our flexible Fractional CIO Model provides you with interim advisory expertise.

We have established strong partnerships with leading technology vendors.

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When time and resources are limited by daily demands and execution, it can be difficult to focus on building your IT strategy.

Our products allow you to focus on innovating. We can help you implement a GxP-compliant framework for every layer of your tech stack and maintain your validation.

Manage your validation workload, so you can focus on product innovation.

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Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

SaMD can be used on various cloud-based networks and manufacturers must understand and interpret regulations and guidelines that apply to them.

This webinar addressed critical SaMD regulations, guidelines, and implications for your quality management system (QMS) and helps you think through your approach for achieving a compliant IT development environment.

About the Presenters

Stepheni Norton, Director of Product Management, Digital and Cloud Solutions

Jay Crowley, Vice President of Medical Device Solutions and Services