{"id":1828,"date":"2024-05-16T16:39:22","date_gmt":"2024-05-16T14:39:22","guid":{"rendered":"https:\/\/www.bayoosoft.com\/unkategorisiert\/bayoosoft-themis-documentation-guide\/"},"modified":"2025-03-06T10:17:43","modified_gmt":"2025-03-06T09:17:43","slug":"bayoosoft-themis-documentation-guide","status":"publish","type":"post","link":"https:\/\/www.bayoosoft.com\/en\/product\/bayoosoft-themis-documentation-guide\/","title":{"rendered":"BAYOOSOFT Themis Documentation Guide"},"content":{"rendered":"

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Documentation Guide<\/h1><\/div>

Which documents must be submitted to the notified body for approval? What is the current status of the information supplied? Who is currently working on it and what do you still need to approve? <\/p>\n

Do you ask yourself questions like these every day? Get transparency and an overview with the Themis Documentation Guide.<\/p>\n<\/div><\/div><\/div>

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Which documents must be submitted to the notified body for approval? What is the current status of the information supplied? Who is currently working on it and what do you still need to approve? <\/p>\n

Do you ask yourself questions like these every day? Get transparency and an overview with the Themis Documentation Guide.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

As regulatory requirements continue to rise, the world of work is becoming increasingly volatile. Issues such as collaboration, growing teams and cross-location working are now commonplace in the world of medical device manufacturers. <\/p>\n

This is exactly why BAYOOSOFT Themis is redesigning the way technical documentation is done \u2013 holistically, innovatively, individually and globally.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

An overview: All features and options<\/h2><\/div>\n
\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
FEATURE<\/th>\nCLOUD HOSTED<\/th>\nON PREMISE<\/th>\n<\/tr>\n<\/thead>\n
Figure Standard requirements<\/td>\nMDR 2017\/745
\nIVDR2017\/746<\/td>\n		MDR 2017\/745
\nIVDR 2017\/746<\/td>\n<\/tr>\n
Document management<\/td>\n\u2714<\/td>\n\u2714<\/td>\n<\/tr>\n
Traceability<\/td>\n\u2714<\/td>\n\u2714<\/td>\n<\/tr>\n
Generation of technical documentation file (incl. structure)<\/td>\n\u2714<\/td>\n\u2714<\/td>\n<\/tr>\n
Team collaboration options<\/td>\n\u2714<\/td>\n\u2714<\/td>\n<\/tr>\n
Versioning and release workflow<\/td>\n\u2714<\/td>\n\u2714<\/td>\n<\/tr>\n
Audit trail &and version history<\/td>\n\u2714<\/td>\n\u2714<\/td>\n<\/tr>\n
Validation acc. ISO 13485 <\/td>\nThe environment is validated by the manufacturer<\/td>\nPrepared validation forms are provided<\/td>\n<\/tr>\n
Optional services<\/td>\n30 days free trial period, application training<\/td>\n30 days free trial period, installation support, application training, validation service<\/td>\n<\/tr>\n
Technical support<\/td>\n\u2714<\/td>\n\u2714<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n
\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
FEATURE<\/th>\nCLOUD HOSTED<\/th>\nON PREMISE<\/th>\n<\/tr>\n<\/thead>\n
Figure
\nStandard requirements<\/td>\n		MDR 2017\/745
\nIVDR2017\/746<\/td>\n		MDR 2017\/745
\nIVDR 2017\/746<\/td>\n<\/tr>\n
Document management<\/td>\n\u2714<\/td>\n\u2714<\/td>\n<\/tr>\n
Traceability<\/td>\n\u2714<\/td>\n\u2714<\/td>\n<\/tr>\n
Generation of technical
\ndocumentation file
\n(incl. structure)<\/td>\n		\u2714<\/td>\n\u2714<\/td>\n<\/tr>\n
Team collaboration options<\/td>\n\u2714<\/td>\n\u2714<\/td>\n<\/tr>\n
Versioning &
\nRelease workflow<\/td>\n		\u2714<\/td>\n\u2714<\/td>\n<\/tr>\n
Audit Trail &
\nVersion history<\/td>\n		\u2714<\/td>\n\u2714<\/td>\n<\/tr>\n
Validation
\nacc. ISO 13485<\/td>\n		The
\nenvironment is validated by the
\nmanufacturer<\/td>\n		Prepared
\nvalidation forms
\nare made available at\n<\/td>\n<\/tr>\n
Optional
\nservices<\/td>\n		30 days
\nfree
\ntrial period,
\napplication training<\/td>\n		30 days free
\ntrial period,
\ninstallation support,
\napplication training,
\nvalidation service<\/td>\n<\/tr>\n
Technical
\nSupport<\/td>\n		\u2714<\/td>\n\u2714<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n<\/div>\n<\/div><\/div><\/div><\/div>

Other modules that might interest you.<\/h2><\/div><\/div><\/div>
<\/i>
Risk Manager<\/h5><\/div>
<\/div>

Risk management in accordance with ISO 14971: Whether PHA or FMEA – you are guided through all work steps in a structured manner.<\/span><\/p>\n<\/div>

Learn more<\/span><\/i><\/a><\/div><\/div><\/div>
<\/i>
Device Validation Manager<\/h5><\/div>
<\/div>

Your fast track to the release of your medical or IVD product: plan and document all tests centrally.<\/p>\n<\/div>

Learn more<\/span><\/i><\/a><\/div><\/div><\/div>
<\/i>
Requirements Engineer<\/h5><\/div>
<\/div>

Manage all requirements (MDR, IVDR, general product requirements, …) in a clear and structured way in one central location.<\/span><\/p>\n<\/div>

Learn more<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div>
<\/span><\/div><\/div><\/div><\/div>

Svenja Winkler
\n<\/strong>CEO<\/p>\n<\/div><\/div><\/div><\/div>

How to contact us<\/h3><\/div>

How would you like to work in the future?<\/p>\n

Be part of it and shape the Tech Doc of tomorrow with us. Send us a short message and our team will take care of your request immediately.<\/p>\n<\/div><\/div><\/div>

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