making a medical device?

We've got you covered.  myQualityCloud makes Google Drive into a QMS that satisfies your government required record keeping needs. 

As you probably know, to sell a Medical Device, a QMS (Quality Management System) is required by most governments.  A QMS contains government required documents: Quality Manual, Procedures, Work Instructions, Forms and Signed Records. 

We cover every type of Medical Device QMS. 

US FDA

Europe ISO 13485 & CE

Rest of World

 
 
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A Compliant QMS on Google Drive. 

Includes everything you need: Quality Manual, Procedures, Work Instructions, Forms and Signed Records. 

  •  21 CFR Part 11 compliant digital signatures, with the click of a button. 
    • We'll help you submit FDA required paperwork for Part 11. 
    • A part 11 compliance audit is included in your subscription. 
    • Annual certification and recertification to 21CFR part 11 is
  • Optional Quality Manual based on 21CFR820
  • Classification Determination Assistance
  • Full GMP procedures and record forms
  • 21CFR801, 803, 806, 820 and 830 procedures and record forms
  • IQ’s for each record form giving:
    • Training record on how to use each record form.
    • Installation Qualification required by many standards including 9001, 13485 and FDA QSR
    • User training on how to perform their own IQ for subsequent revisions
      Document control approval for the first issue of each record form
 
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US FDA - QMS FOR CLASS ONE PRODUCTS WITHOUT A FULL cGMP

  • US FDA complaints procedures and record forms
  • Basic document controls
  • Reporting, procedures and record forms
  • Part 11 compliant signature on Google docs
    • Assistance with documenting and filing the mandatory digital signature affidavit
    • At go-live, a part 11 compliance audit is performed based on a part 11 compliance protocol
    • One year duration part 11 compliance certificate is provided for the go-live configuration
 
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Europe CE - QMS FOR ISO 13485:2016 - PLUS CE MARKING

We'll help with everything you need. 

  • Classification Determination
  • Essential requirements checklists (ERC) assistance for the appropriate directives
  • All related directives compliance requirements
  • Quality Manual based on the latest 13485:2016
  • Record Forms and Procedures based on the the anticipated 2017 IVDD or 2017 MDD
  • Procedures and Record Forms identified as needed for each client’s individual needs
  • IQ’s for each Record Form:
    • Training is performed and recorded on how to use the record form
    • Installation Qualification required by many standards
    • User training on how to perform an IQ for subsequent revisions
    • Document control approval for the first issue of each record form
 
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Worldwide / MDSAP - QMS FOR ISO 13485:2016 ONLY

  • Quality Manual based on the latest ISO 13485:2016
  • As needed procedures and record forms
  • Optional IQ’s for each record form giving:
    • Training record on how to use the record form
    • Installation Qualification required by many standards
    • User training on how to perform an IQ for subsequent revisions
    • Document control approval for the first issue of each record form
 
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Worldwide - QMS FOR COUNTRIES OUTSIDE US & EU

  • For all markets worldwide we can help you identify if there are government regulated standards for your medical devices & create a custom Quality System to satisfy those standards.