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<h3>Want more info?</h3>

We get it: you need a superior software solution, but don’t know where to begin. Download this handy PDF by clicking the link below, and we’ll guide you through our process and showcase other clients that have had amazing successes.

<h5 style=”color: #444444;”>Have more questions?</h5>

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<span style=”color: #b2dd4c; line-height: 20px; font-weight: 700;”><a href=”mailto:info@fullspectrumsoftware.com”>info@fullspectrumsoftware.com</a></span><br />

<span style=”color: #b2dd4c; line-height: 20px; font-weight: 700;”><a href=”tel:+1+15086206400″>+1 (508) 620-6400<a/></span>

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Process Compliance

Compliance to standards like ISO 13485:2016 is essential to medical device development. It requires focused attention to details and processes.  The key to our clients’ success is collaboration with a team who has been there and done that in the regulated software space. Full Spectrum Software has a well-established Quality Management System (QMS) and has been ISO 13485 certified since 2009. Thanks to our matured QMS, we were able to help our clients obtain FDA approvals within record times!

Our standard operating procedures and templates provide the framework for compliance with all applicable international standards, including:

  • 21 CFR 820 – Quality System Regulations
  • IEC 62304 Software Development Life Cycle
  • ISO 14971 Risk Management
  • IEC 62366-1 Usability Engineering
  • AAMI TIR45 Agile Software Development
  • ISO 9001

 

When our clients do not have their own QMS or one that includes software, Full Spectrum’s QMS provides all of the tools necessary for the complete software development lifecycle, and your Full Spectrum Software team will deliver a professionally-packaged Design History File. When our clients do have their own QMS, our team is also well-versed in working within the clients’ QMS environments.

Every project is unique. The particular processes and deliverables used in any project depend on the scope, magnitude, and safety classification of the product. Your Full Spectrum Software team will help lay out a plan to work within an ISO 13485:2016 compliant framework to:

  • Determine the right set of processes and deliverables – as simple as possible and as complex as necessary
  • Overcome technical challenges early
  • Provide complete traceability throughout the product realization cycle
  • Ensure you have what you need for FDA submission

Ready to Get Started?

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