Developing FDA Compliant Medical Device Software

 Does Not Have to Hurt! Baby

 

  • Have a Software Quality System in place right away that is compliant with all current US FDA and EU Medical Software Regulations.  
  • Help to Achieve Rapid and Successful FDA Approval of your Medical Device Software. 
  • Prevent unfavorable FDA Audit of Software Quality System.   
  • Take the mystery and headache out of planning and developing regulated Medical Device Software.

Sign up to the right for your Complimentary List of Essential Documents and Templates You Need for IEC EN62304 Compliancy

 

New!  

Ask us about our Complete EN/IEC 62304 Fully Compliant Policy, Procedure, and Template Package.

Implement a Software Quality System rapidly and to full compliance with both current US and European ISO regulations.

Contact us at: info@signetmedicalsystems.com or 1-855-342-4959 for more information

 

 

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NEWS! 

Nancy Knettell will be a featured speaker in May 4-6, 2015 at the 10x Medical Device Conference, Hilton San Diego Mission Valley.

Check out the website here: 10X Medical Device Conference

 

Finally Your Ticket to China

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Having your Medical Device Software approved by the Chinese FDA is no longer a mystery. 

Contact us at: info@signetmedicalsystems.com or 1-978-270-5053 for more information

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CONTACT INFO:

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info@signetmedicalsystems.com

1-978-270-5053



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List of Essential Documents and Templates You Need for IEC EN62304 Compliancy

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