# SimpliMedica: Quality and Regulatory Consultancy for Medical Devices

> Medical device regulatory consultancy services designed to help you manage the challenges of compliance and bring your products to market efficiently\.

Generated by Yoast SEO v28.0, this is an llms.txt file, meant for consumption by LLMs.

## Pages
- [Home](https://simplimedica.com/)
- [Contact](https://simplimedica.com/contact/)
- [US \& EU Medical Device Regulatory \& Market Access Consulting](https://simplimedica.com/us-eu-market-access/)
- [Consultant on Demand](https://simplimedica.com/consultant-on-demand/)
- [Quality Management System](https://simplimedica.com/qms/)

## Posts
- [Med\-Tech Start\-Up Networking Morning](https://simplimedica.com/med-tech-networking-morning-2026/)
- [January 2025 \- Medical Devices Regulatory Insights](https://simplimedica.com/january-2025-medical-devices-regulatory-insights/)

## Products
- [Software as Medical Device Start\-Up Template Package](https://simplimedica.com/product/software-as-medical-device-start-up-template-package/): \<p class="p1" style="text\-align: justify;"\>\<span class="s1"\>If you are a start\-up company developing an app or health software that could have an intended medical purpose, then you will need to consider the adoption of the recognized standard for Medical Device Software EN 62304: 2006\+A1: 2015\. The standard guides you to output a number of documents that can be used as Verification and Validation of the software in preparation for submission to the notified bodies or the FDA etc\.\</span\>\</p\>
\<p class="p1" style="text\-align: justify;"\>\<span class="s1"\>Pharmi Med has prepared these templates to help start\-up companies who traditionally do not have Medical Device experience but usually from a Software Engineering background but need to penetrate the market\. We have reduced the burden by creating these templates for your engineers\. If you need further assistance in the regulatory framework of submissions please contact us here\</span\>\</p\>
\<p style="text\-align: left;"\>You can preview the document below:\</p\>
\<p style="text\-align: left;"\>\[real3dflipbook id='45'\]\</p\>
\<p style="text\-align: left;"\>You may purchase the full package including instructions for use below\.\</p\>
- [Liquid Filler IOQ](https://simplimedica.com/product/liquid-filler-ioq/): The Liquid Filler IOQ template is a versatile template for filling lines, and without a vision system\.

A preview of the the IOQ for Validation Protocol is available here:

\[real3dflipbook id='35'\]

You may purchase the full 27 page document in convenient Microsoft Word format including instructions for use below\.
- [Capper IOQ Template](https://simplimedica.com/product/capper-ioq-template/): The Capper IOQ template is a versatile template for all capping machines, and without a vision system\.

A preview of the the IOQ for Validation Protocol is available here:

\[real3dflipbook id='33'\]

You may purchase the full 32 page document in convenient Microsoft Word format including instructions for use below\.
- [Blister Machine IOQ Template \(without Vision System\)](https://simplimedica.com/product/blister-machine-ioq-template-without-vision-system/): \<p style="text\-align: justify;"\>The Blister Machine IOQ template is a versatile template for basic blister machines with less complexity of material handling, and without a vision system\.\</p\>
\<p style="text\-align: justify;"\>A preview of the the IOQ for Validation Protocol is available here:\</p\>
\[real3dflipbook id='32'\]
\<p style="text\-align: justify;"\>You may purchase the full 25 page document in convenient Microsoft Word format including instructions for use below\.\</p\>
- [IOPQ for Freezer Validation](https://simplimedica.com/product/iopq-for-freezer-validation/): \<p style="text\-align: justify;"\>The IOPQ \(Installation Operational and Performance Qualification\) for Freezer Validation can be used as a versatile document aimed at thermal mapping for fridge, freezers and may be adapted for oven validations\.\</p\>
\<p style="text\-align: justify;"\>A preview of the the IOPQ Validation Protocol is available here:\</p\>
\[real3dflipbook id='31'\]
\<p style="text\-align: justify;"\>You may purchase the full 24 page document in convenient Microsoft Word format including instructions for use below\.\</p\>

## Real3D Flipbook
- [Guidance for EU MDR Drug Device combination products](https://simplimedica.com/?r3d=guidance-for-eu-mdr-drug-device-combination-products)
- [Guidance for EU MDR \- Systems and Procedure Packs](https://simplimedica.com/?r3d=guidance-for-eu-mdr-systems-and-procedure-packs)
- [MDR Complete Package](https://simplimedica.com/?r3d=mdr-complete-package)
- [Guidance for EU MDR Software as a Medical Device \(SaMD\)](https://simplimedica.com/?r3d=guidance-for-eu-mdr-software-as-a-medical-device-samd)
- [CE Technical File](https://simplimedica.com/?r3d=ce-technical-file)

## Mega Menu Items
- [mega\-item\-3327](https://simplimedica.com/?crafto-mega-menu=mega-item-3327)
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- [mega\-item\-3379](https://simplimedica.com/?crafto-mega-menu=mega-item-3379)

## Theme Builder
- [Header](https://simplimedica.com/?themebuilder=header)
- [Footer](https://simplimedica.com/?themebuilder=footer)
- [Separate Breadcrumbs](https://simplimedica.com/?themebuilder=separate-breadcrumbs)
- [Page Not Found](https://simplimedica.com/?themebuilder=page-not-found)
- [Post Archive Template](https://simplimedica.com/?themebuilder=lawyer-post-archive)

## Categories
- [NEWS](https://simplimedica.com/category/news/)
- [PODCASTS](https://simplimedica.com/category/podcasts/)
- [WEBINARS](https://simplimedica.com/category/webinars/)

## Tags
- [free webinar](https://simplimedica.com/tag/free-webinar/)
- [process validation](https://simplimedica.com/tag/process-validation/)
- [medical devices](https://simplimedica.com/tag/medical-devices/)

## Product categories
- [Medical Device Templates](https://simplimedica.com/product-category/medical-device-templates/)
- [Pharmaceutical Templates](https://simplimedica.com/product-category/pharmaceutical-templates/)
- [MDR \& IVDR](https://simplimedica.com/product-category/mdr-ivdr/)
- [Equipment Validation Templates](https://simplimedica.com/product-category/equipment-validation/)
- [Design Control](https://simplimedica.com/product-category/design-control/)

## Product tags
- [medical device templates](https://simplimedica.com/product-tag/medical-device-templates/)
- [pharmaceutical templates](https://simplimedica.com/product-tag/pharmaceutical-templates/)
- [general template](https://simplimedica.com/product-tag/general-template/)
- [pharmaceutical and medical device template](https://simplimedica.com/product-tag/pharmaceutical-and-medical-device-template/)
- [medical device template](https://simplimedica.com/product-tag/medical-device-template/)

## Optional
- [Sitemap index](https://simplimedica.com/sitemap_index.xml)