{"id":7461,"date":"2026-02-09T13:45:16","date_gmt":"2026-02-09T12:45:16","guid":{"rendered":"https:\/\/www.bayoosoft.com\/?p=7461"},"modified":"2026-02-16T13:20:44","modified_gmt":"2026-02-16T12:20:44","slug":"bayoosoft-themis-and-regulations-norms-and-standards","status":"publish","type":"post","link":"https:\/\/www.bayoosoft.com\/en\/product\/bayoosoft-themis-and-regulations-norms-and-standards\/","title":{"rendered":"BAYOOSOFT Themis and regulations, norms and standards"},"content":{"rendered":"

BAYOOSOFT Themis<\/h2><\/div>

Always compliant: Your single source of truth<\/span> for all relevant regulations, norms & standards<\/h1><\/div>
Test Themis now<\/span><\/a><\/div><\/div><\/div><\/div><\/div>

BAYOOSOFT Themis<\/h2><\/div>\n

Always compliant: Your single source of truth<\/span> for all relevant regulations, norms & standards<\/h1><\/div>\n
Request a free initial consultation<\/span><\/a><\/div><\/div><\/div><\/div><\/div>

In highly regulated industries, compliance with a large number of norms, standards and legal requirements is not just an obligation, but crucial for the long-term success and marketability of your products. However, managing these requirements – from monitoring new regulations to providing seamless evidence – is time-consuming and ties up valuable resources. Every manual update and every search for evidence for audits delays progress. <\/p>\n

BAYOOSOFT Themis integrates the requirements of the most important regulations directly into your single source of truth, enables process-guided document creation and ensures that your information is always networked and traceable. This allows you to turn time-consuming compliance tasks into a strategic advantage. Master approvals and audits with system and confidence to bring your products to market faster and more securely. <\/p>\n<\/div><\/div><\/div>

Get to know the advantages of BAYOOSOFT Themis<\/h2><\/div>

Why is BAYOOSOFT Themis really worth it? See for yourself: All functions, concrete advantages and real examples from practice at a glance. <\/p>\n<\/div>

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

BAYOOSOFT Themis and the relevant regulations, norms & standards<\/h2><\/div>

BAYOOSOFT Themis covers all relevant standards and regulations in medical technology – from MDR and IVDR to international standards and country-specific market approvals. Thanks to the modular structure, you can use exactly the packages you need for your compliance.
\nThe overview shows you which Themis modules apply to which standards and how you can set up your documentation efficiently and audit-proof. <\/p>\n<\/div><\/div><\/div>

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MDR (Medical Device Regulation) 2017\/745<\/h4><\/h5><\/div>

Systematic fulfillment of the requirements for technical documentation and the GSPR (Annex I). The process-guided structure ensures that you work through all points systematically. <\/p>\n<\/div>

<\/div><\/div>
Documentation Guide<\/span><\/a><\/div>
Requirements Pack<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
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IVDR (In Vitro Diagnostic Regulation) 2017\/746<\/h4><\/h5><\/div>
Clear structuring and process-guided creation of technical documentation for IVD. The integrated instructions ensure compliance with performance requirements. <\/header>\n<\/div>
<\/div><\/div>
Documentation Guide<\/span><\/a><\/div>
Requirements Engineering<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
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ISO 14971 (risk management)<\/h4><\/h5><\/div>

Support established methods such as PHA and FMEA in a process-led manner. Link all risk elements together and ensure complete documentation of your risk file. <\/p>\n<\/div>

<\/div><\/div>
Risk Pack<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
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IEC 62304 (software life cycle)<\/h4><\/h5><\/div>

Manage the software requirements in a structured manner. Ensure seamless traceability between requirements and verifications in accordance with IEC 62304. <\/p>\n<\/div>

<\/div><\/div>
Requirements Pack<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
<\/i>

IEC 60601-1 (Medical electrical equipment)<\/h4><\/h5><\/div>
Link relevant safety and performance requirements with evidence and ensure seamless traceability in your documentation.<\/header>\n<\/div>
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Requirements Pack<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
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ISO 80001-1 (Risk management IT networks)<\/h4><\/h5><\/div>

Systematically record and manage risks and measures in the context of IT networks to support the requirements of this complex standard.<\/p>\n<\/div>

<\/div><\/div>
Risk Pack<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
<\/i>

ISO 27001<\/h4><\/h5><\/div>

Build your ISMS according to the standard. Manage security measures and risks efficiently and have all relevant information centrally available for audits. <\/p>\n<\/div>

<\/div><\/div>
ISO Guide<\/span><\/a><\/div>
Management Systems<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
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ISO 9001<\/h4><\/h5><\/div>

Enable the structured development and efficient maintenance of your QMS, including the linking of processes, roles and requirements<\/p>\n<\/div>

<\/div><\/div>
ISO Guide<\/span><\/a><\/div>
Management Systems<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
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ISO 13485<\/h4><\/h5><\/div>

Manage your QM system in a process-led manner, link all requirements and ensure seamless traceability throughout the entire company. <\/p>\n<\/div>

<\/div><\/div>
ISO Guide<\/span><\/a><\/div>
Management Systems<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
<\/i>

Canada (Health Canada) – MDSAP<\/h4><\/h5><\/div>

Coverage of Canadian GSPR requirements in the GSPR questionnaire and support of compliance for MDSAP certification – mandatory in Canada.<\/p>\n<\/div>

<\/div><\/div>
Requirements Pack<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
<\/i>

USA (FDA) – MDSAP<\/h4><\/h5><\/div>

Compliance with the GSPR requirements of the US FDA (21 CFR Part 820) through the GSPR questionnaire to simplify audits and inspections.<\/p>\n<\/div>

<\/div><\/div>
Requirements Pack<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
<\/i>

Australia (TGA) – MDSAP<\/h4><\/h5><\/div>

The requirements of the TGA are covered by the GSPR questionnaire and serve as an important input for obtaining market approval.<\/p>\n<\/div>

<\/div><\/div>
Requirements Pack<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
<\/i>

Brazil (ANVISA) – MDSAP<\/h4><\/h5><\/div>

Mapping of the Brazilian GSPR requirements of ANVISA (RDC) in the GSPR questionnaire and support of the assessment before and after market launch.<\/p>\n<\/div>

<\/div><\/div>
Requirements Pack<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
<\/i>

Japan (MHLW\/PMDA) – MDSAP<\/h4><\/h5><\/div>

Consideration of the GSPR requirements of the Japanese market (MHLW\/PMDA) via the GSPR questionnaire to simplify the approval processes.<\/p>\n<\/div>

<\/div><\/div>
Requirements Pack<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
<\/i>

MDCG documents (e.g. clinical evaluation)<\/h4><\/h5><\/div>

Support the structure and content of your clinical evaluation (CER) in accordance with the MDCG guidelines and ensure the traceability of all documents.<\/p>\n<\/div>

<\/div><\/div>
Device Validation Pack<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
<\/i>

IEC 62366<\/h4><\/h5><\/div>

Carry out usability engineering in a process-led manner. The seamless linking of risk analysis and usability ensures conformity. <\/p>\n<\/div>

<\/div><\/div>
Device Validation Pack<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div>
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(EU) 2023\/1230 (MVO)<\/h4><\/h5><\/div>

Create the required conformity documentation in parallel and consistently with the medical device documentation in the same single source of truth. This ensures compliance with both sets of regulations. <\/p>\n<\/div>

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Access Management<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>

Validation of BAYOOSOFT Themis: Your added security<\/h2><\/div>

The validation of computerized systems is a central component of regulated environments – especially in the context of medical devices and quality management systems. The aim is to provide traceable proof that requirements are implemented correctly and that software can be used reliably in the intended area of application. <\/p>\n

In practice, this means that requirements must be clearly defined, implemented in a structured manner and documented in a verifiable manner. This is exactly where BAYOOSOFT Themis comes in. <\/p>\n<\/div>

<\/span><\/div>

The V-model clarifies the underlying validation logic: requirements at different levels are systematically specified and validated through suitable inspection and test steps. This structure forms the basis for transparency, traceability and audit security in regulated processes. <\/p>\n<\/div><\/div><\/div>

Comprehensively validated and standard-compliant<\/h3><\/div>

BAYOOSOFT Themis is a validated software solution developed for use in regulated environments. The software meets the relevant requirements for computerized systems and supports companies in implementing regulatory requirements such as ISO 13485, MDR or ISO 27001 in a structured and efficient manner. <\/p>\n

Themis digitizes and centralizes documentation and management processes. This reduces manual activities, keeps information consistent and documents changes in a traceable manner – a stable basis for daily operations as well as for audits. <\/p>\n<\/div><\/div><\/div>

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Validation security with a system<\/h2><\/div>

With BAYOOSOFT Themis, you use a tested software solution that supports you in the standard-compliant implementation of your processes – transparent, structured and auditable.<\/p>\n<\/div>

Get to know Themis now<\/span><\/a><\/div><\/div><\/div>
<\/i><\/div><\/div><\/div><\/div><\/div><\/div><\/div>

Durchst\u00f6bern Sie unsere Ressourcen<\/h2><\/div>

Ob Sie nach konkreten L\u00f6sungsans\u00e4tzen suchen oder sich \u00fcber aktuelle Trends informieren m\u00f6chten \u2013 in unseren Blogs, Whitepapers und Events finden Sie Impulse f\u00fcr Ihre n\u00e4chsten Schritte.<\/p>\n<\/div>

\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\"NIS2-und-ISO-27001-Themis\"\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/div>
NIS2 and ISO 27001: How companies can make their ISMS fit for the new requirements<\/a><\/h5><\/div>
<\/div>
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MedTech Compliance: From chaos to structure with the right document management<\/a><\/h5><\/div>
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BAYOOSOFT @COMPAMED 2026 (16.11-19.11.26)<\/a><\/h5><\/div>
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BAYOOSOFT @it-sa 2026 (27-29.10.2026)<\/a><\/h5><\/div>
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BAYOOSOFT @MedTecLIVE 2026 (05-07.05.2026)<\/a><\/h5><\/div>
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Schreiben Sie mit uns die n\u00e4chste Erfolgsgeschichte<\/h2><\/div>

Vereinbaren Sie jetzt einen unverbindlichen Termin f\u00fcr eine kostenfreie Erstberatung, informieren Sie sich in Ruhe selbst \u00fcber die Vorteile des Access Manager – oder lassen Sie sich ganz bequem von uns beraten.<\/p>\n<\/div><\/div><\/div>

<\/span><\/div>

Arrange a demo now and experience Themis live<\/p>\n<\/div>

Arrange a demo now<\/span><\/a><\/div><\/div><\/div>
<\/span><\/div>

Why BAYOOSOFT Themis is really worth it<\/p>\n<\/div>

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

Get in touch with us now<\/p>\n<\/div>

Contact us now<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":4,"featured_media":7433,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[39,38],"tags":[],"class_list":["post-7461","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bayoosoft-themis-en","category-product"],"yoast_head":"\nBAYOOSOFT Themis regulations: MDR, IVDR & ISO standards<\/title>\n<meta name=\"description\" content=\"BAYOOSOFT Themis regulations: MDR, IVDR & ISO standards in a single source of truth. Process-guided, audit-proof, GAMP-5 validated.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.bayoosoft.com\/en\/product\/bayoosoft-themis-and-regulations-norms-and-standards\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BAYOOSOFT Themis and regulations, norms and standards\" \/>\n<meta property=\"og:description\" content=\"BAYOOSOFT Themis regulations: MDR, IVDR & ISO standards in a single source of truth. 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