---
title: MedTech and Pharma
description: We support MedTech and HealthTech companies, as well as organizations operating in regulated environments in the pharmaceutical and laboratory sectors (GLP) in the DACH region, with the development, modernization, and maintenance of software
image: https://vialutions.com/hubfs/Office%20scenes/jqp_20241202_362-Edit.jpg
---

Software for regulated environments

# Software that does more than just work – it stands up to regulatory requirements.

For faster time to market – and confident audit readiness.

We support MedTech and HealthTech companies, as well as organizations operating in regulated Pharma and laboratory environments ([GLP](https://vialutions.com/medtech-and-pharma#glp)) across the DACH region with software development, modernization, and maintenance. We work in line with regulatory frameworks such as [MDR](https://vialutions.com/medtech-and-pharma#mdr), [ISO 13485](https://vialutions.com/medtech-and-pharma#iso13485), and [IEC 62304](https://vialutions.com/medtech-and-pharma#iec62304), with a strong focus on data integrity, auditability, and traceable processes.

We work within existing [QMS](https://vialutions.com/medtech-and-pharma#qms) frameworks – not alongside them.

Working within existing QMS structures End-to-end traceability from requirements to verification and validation Audit-ready documentation and structured processes DACH-based partner with regulatory understanding

✓ Prepared for supplier audits and regulatory inspections

✓ We adapt to existing processes – not the other way around

✓ We understand not just software – but also the conditions under which it is developed

[ Schedule a no-obligation consultation ](https://vialutions.com/medtech-and-pharma#kontakt) 30 minutes · no obligation · no preparation required

![Software for regulated environments](https://vialutions.com/hubfs/medtech%20picture.jpg)

## The types of companies we are especially relevant for

Built for organizations that need to take software in regulated environments seriously.

### Mid-sized MedTech companies (50–500 employees)

Hardware-driven products with a growing software component

Limited in-house software capacity

Existing legacy systems that need to be stabilized, modernized, or further developed

### HealthTech, Pharma & GLP-related environments

Rapid growth alongside increasing regulatory demands

Need for structured software development

Systems with high requirements for data integrity, auditability, and traceable processes

![](https://vialutions.com/hubfs/PMD_logo.png)

![](https://vialutions.com/hubfs/raylytic.png)

![](https://vialutions.com/hubfs/20220627_neoq_logo_green_white.webp)

![](https://vialutions.com/hubfs/biomedion-logo-2020%20(1).webp)

![](https://vialutions.com/hubfs/semalytix.png)

![](https://vialutions.com/hubfs/doc2read.png)

![](https://vialutions.com/hubfs/blutspendedienst.jpg)

![](https://vialutions.com/hs-fs/hubfs/CCRI_Logo_transparent.col.gif?width=57&height=43&name=CCRI_Logo_transparent.col.gif)

![Toosonix-logo-for-web](https://vialutions.com/hs-fs/hubfs/Toosonix-logo-for-web.png?width=122&height=54&name=Toosonix-logo-for-web.png)

## Common challenges our clients face

These issues are not just technical – they directly affect audit readiness and market access.

### Documentation

Missing or inadequate documentation makes audits, validation, and clean handovers significantly more difficult.

### Legacy systems

Long-standing systems slow down further development, increase risk, and concentrate critical knowledge in individual team members.

### Traceability

Lack of traceability across requirements, code, tests, and changes quickly becomes a regulatory risk.

## The reality of MedTech and regulated environments

### Software is not just functionality – it is part of the evidence.

In MedTech, software means: every requirement must be traceable, every change is subject to control, and every function can be regulatory-relevant. In Pharma-related and GLP-regulated environments, software is not just functionality – it forms part of the regulatory evidence.

Requirement → Code → Test → Validation

This is exactly where many software service providers reach their limits.

We are prepared for it.

## Our approach

We do not work “despite” regulation – but within that reality.

### Development aligned with regulatory requirements

Guided by IEC 62304

Understanding of software safety classes

Integration into existing ISO 13485 processes

### Working in GLP and Pharma-related environments

Support for systems with data integrity requirements (ALCOA+)

Structured capture and traceability of raw data

Working within SOP-based processes

Support for validated systems

Preparation for audits and inspections

### Systems with data integrity requirements

Ensuring complete audit trails

Preventing uncontrolled changes

Traceability across all data flows

Support for regulatory data requirements

### Traceability from day one

Linking requirements, code, and tests

Clear structure in Jira / Git / test systems

Auditable development processes

### Documentation that is actually usable

Architecture & design documentation

Test protocols & change logs

Support with verification & validation

### Pragmatic approach to compliance

No overengineering

Adapting to existing processes

Working with QA/RA instead of creating friction

Key differentiator

## Legacy systems? We take responsibility.

The reality in many MedTech, Pharma, and Life Sciences companies: systems have evolved over years, documentation is incomplete, technologies are outdated, and key knowledge is concentrated in individual people.

We take responsibility for systems that are already in operation.

### Typical scenarios

1Migration to new operating systems or hardware platforms

2Refactoring under regulatory requirements

3Stabilization of critical applications

4Further development of existing products

### Our approach

Analysis of existing risks

Structured documentation

Controlled changes (change control)

Step-by-step modernization

Without putting existing certifications at risk.

## What we take on in practice

### Development

Custom software (desktop, cloud, embedded) as well as extension of existing products.

### Modernization

Transformation of legacy systems, and improvement of architecture, stability, and performance.

### Maintenance & further development

Long-term support, defect analysis, stabilization, and controlled releases.

### Compliance-related support

Documentation, test strategies, and preparation for audits and regulatory inspections.

## Reference projects

Selected projects from MedTech, Pharma, and regulated environments

All projects delivered under requirements for quality, documentation, and compliance.

MedTech

![PMD_logo](https://vialutions.com/hs-fs/hubfs/PMD_logo.png?width=109&height=42&name=PMD_logo.png)

### PMD Solutions

Rapid delivery of a mobile software layer to extend a MedTech solution for sleep-related breathing disorders and accelerate time to market.

MedTech

### Implantable medical devices

### Logo under NDA

Support in the development of a MedTech solution for implantable medical devices – including a physician application, backend, and firmware updates – enabling secure patient data handling and reliable further development of a regulated product.

Quality & Audit

![blutspendedienst](https://vialutions.com/hs-fs/hubfs/blutspendedienst.jpg?width=131&height=43&name=blutspendedienst.jpg)

### Blood donation service

Replacement of an existing DMS with a modern platform, including full migration of documents, histories, and metadata to ensure future-proof quality assurance.

Life Sciences

![biomedion-logo-2020 (1)](https://vialutions.com/hs-fs/hubfs/biomedion-logo-2020%20(1).webp?width=248&height=39&name=biomedion-logo-2020%20(1).webp)

### biomedion

We took over development, further development, and operations for this Life Sciences solution, ensuring stability, continuous evolution, and long-term operational reliability.

Pharma & Insights

![semalytix](https://vialutions.com/hs-fs/hubfs/semalytix.png?width=106&height=39&name=semalytix.png)

### Semalytix

We contributed to the development of one of the world’s largest archives of patient and physician data – enabling valuable insights for informed decision-making in Pharma and healthcare.

HealthTech

![doc2read](https://vialutions.com/hs-fs/hubfs/doc2read.png?width=119&height=39&name=doc2read.png)

### DocToRead

Design, development, and continuous optimization of the AI-based DocToRead app, which automatically translates medical language into understandable content – improving patient education and enabling more efficient communication in healthcare.

MedTech / Radiology

![20220627_neoq_logo_green_white](https://vialutions.com/hs-fs/hubfs/20220627_neoq_logo_green_white.webp?width=148&height=37&name=20220627_neoq_logo_green_white.webp)

### Neo Q / RadioReport

Support in the development of the radiology reporting software Radioreport to enable structured reporting – for faster reports, higher quality, and more efficient billing and downstream processing.

MedTech / Radiology

![raylytic](https://vialutions.com/hs-fs/hubfs/raylytic.png?width=263&height=40&name=raylytic.png)

### Raylytic

One key challenge was migrating the existing software into a modern architecture to ensure scalability, maintainability, and future readiness.

Research

![CCRI_Logo_transparent.col](https://vialutions.com/hs-fs/hubfs/CCRI_Logo_transparent.col.gif?width=63&height=55&name=CCRI_Logo_transparent.col.gif)

### St. Anna / Cancer Research Institute

Custom solution for structured extraction of metadata and documents from a third-party system, enabling efficient, reliable data migration and improved data transparency and usability, delivered with flexibility and on-time execution.

MEDTECH

![Toosonix-logo-for-web](https://vialutions.com/hs-fs/hubfs/Toosonix-logo-for-web.png?width=97&height=54&name=Toosonix-logo-for-web.png)

### TooSonix

Development of the user interface and device communication layer for a focused ultrasound solution, enabling reliable interaction between software and medical hardware in a regulated environment.

Why Vialutions

## A partner proven in regulated environments.

Many providers are either classic software houses without regulatory understanding – or large, expensive consultancies with limited flexibility.

**Technical excellence** in business-critical software projects

**Understanding** of regulated environments

**Pragmatic approach** instead of overengineering

✓ Delivering software that works – and stands up to regulatory requirements.

✓ We do not deliver features – we deliver audit-ready solutions.

✓ In healthcare, trust is not a marketing term – it is a regulatory prerequisite.

✓ In Pharma-related and GLP-regulated environments, software is not just functionality – it is part of the regulatory evidence.

## European context

### A partner with solid understanding of market and regulation

Experience with European regulations (MDR, data protection, compliance)

DACH-based partner with understanding of local requirements

Increasing importance of European partners to ensure data sovereignty and regulatory control

Reduced risk from dependencies on non-European technology providers

Especially for sensitive healthcare data, the origin of the technology partner is increasingly becoming a decision-making factor

## When we are the right partner

✓ You operate within a QMS (e.g. ISO 13485)

✓ You need support with development or maintenance

✓ You want to make software audit-ready

✓ You have legacy systems that need modernization

## Your contacts

### [![Andreas Hepfner](https://vialutions.com/hubfs/Mitarbeiter/jqp-20241202-316-Edit-2-5x7.jpg) Andreas Hepfner CEO VIALUTIONS consult GmbH](https://www.linkedin.com/in/andreas-hepfner-685093b4/)

### [![Andreas Pohling](https://vialutions.com/hubfs/Mitarbeiter/jqp-20241202-022-Edit-2-5x7.jpg) Andreas Pohling CEO VIALUTIONS sp. z o.o](https://www.linkedin.com/in/andreaspohling/)

### [![Katharina Lewering](https://vialutions.com/hubfs/Mitarbeiter/jqp-20241202-178-Edit-2-5x7.jpg) Katharina Lewering Business Development DACH](https://www.linkedin.com/in/katharina-lewering-534845122/)

### [![Piotr Stawiński](https://vialutions.com/hubfs/Mitarbeiter/PiotrStawinski2.jpg) Piotr Stawiński Business Development DACH](https://www.linkedin.com/in/stawinskipiotr/)

## Let’s talk about your project

Clear. Direct. No buzzwords.

Whether it is a new development, a legacy system, or regulatory requirements – we review your situation in a structured way and provide an honest assessment.

✓ 30 minutes

✓ No obligation

✓ No preparation required

### Schedule a no-obligation consultation

 

## Glossary – Key Terms in Regulated Environments

Important standards and concepts used in regulated software development.

GLP (Good Laboratory Practice)

A regulatory framework governing non-clinical laboratory studies, ensuring quality, integrity, and reliability of safety testing in areas such as pharmaceuticals and chemicals.

MDR (EU Medical Device Regulation)

The EU regulation (2017/745) defining strict requirements for medical device safety, clinical evaluation, documentation, and post-market surveillance.

ISO 13485

An international quality management standard for medical device companies covering design, development, production, and lifecycle processes.

IEC 62304

A standard defining the software lifecycle processes for medical device software, including development, maintenance, and risk management.

QMS (Quality Management System)

A structured system of processes, documentation, and responsibilities designed to ensure consistent product quality and regulatory compliance.

SOP-based (Standard Operating Procedures)

A way of working based on standardized, documented procedures that ensure consistency, quality, and compliance across processes.

ALCOA+

A data integrity standard ensuring that data is attributable, legible, contemporaneous, original, accurate, and additionally complete, consistent, enduring, and available.

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