Digital solutions for medical technology
Medical technology places the highest demands on safety, efficiency and compliance. With customised software, we support companies in fulfilling regulatory requirements and optimally designing digital processes. From planning to implementation, we accompany the entire digitalisation process and transfer proven concepts to the industry in a targeted manner - for safe and future-proof medical technology.
- Cybersecurity monitoring and updates
- SW maintenance / updates / upgrades
- Change Management & Regulatory Impact Assessments
- Support with approval
- Implementation of authority feedback
- Database interface design
- Approval documentation
- Software deployment
- Development verification
- Cybersecurity (penetration testing)
- Software validation
- Usability evaluation
- Clinical evaluation
- Product development: Software lifecycle / IEC 62304 & cybersecurity
- Requirements management / Product specification
- Risk management / ISO 14971
- Development documentation / Design controls
- Labeling / Instructions for use
- Kick off workshop
- Regulatory strategy
- Identification of target markets, standards & requirements
- Regulatory roadmap
- Project planning & Monitoring
- time, quality, resources
Structured data management.
Secure and efficient data management is essential for innovation and regulatory compliance in medical technology. We help companies to strategically optimise their data infrastructure - with clear structures, seamless traceability and a focus on data governance and cyber security.
From planning to implementation, we support you with a clear roadmap. Our experts ensure that your data management complies with current standards and is flexibly designed to meet the dynamic requirements of medical technology.
Cyber & software security.
Increasing networking makes medical technology a target for cyber attacks. M&M Software develops security solutions that reliably protect your digital systems and IT infrastructures - in compliance with all relevant norms and standards.
We analyse security gaps, optimise development processes and support the implementation of PSIRT processes for a rapid response to incidents. In workshops, we impart practical knowledge on software security and regulatory requirements.
With a customised security strategy, you can secure sensitive data, fulfil compliance requirements and strengthen confidence in your medical technology products.
Our further range of services:
Customised connection to medical databases.
Up-to-date and correct product data is essential for safety and regulatory compliance in medical technology. M&M Software develops solutions that automatically link your data with medical databases such as Eudamed, Swissmedic and the FDA.
Through intelligent automation, we reduce manual effort, minimise sources of error and ensure structured data management. This ensures that your product information is always up-to-date, traceable and legally compliant. A decisive advantage in the context of the Medical Device Regulation (MDR).
AI in medical technology.
Artificial intelligence optimises processes in medical technology: from product development to market approval. It supports companies with regulatory requirements such as MDR, ISO 14971 and the upcoming AI Act through automated documentation, risk analyses and quality checks.
AI can speed up approval processes, detect errors at an early stage and efficiently analyse market data. This reduces manual effort and creates space for value-adding activities. Tasks relating to MDR documentation, certification preparation and market surveillance in particular offer great potential for optimisation.
Digital twin for medical devices.
A digital twin provides a virtual representation of your medical device and enables optimisation throughout the entire life cycle. Manufacturers can analyse usage patterns, improve designs and develop targeted training courses.
New business models such as feature on demand or operator models can also be realised. The digital twin also supports predictive maintenance: by analysing usage data, maintenance requirements are identified at an early stage, downtimes are minimised and device availability is ensured.
With a digital twin, you can optimise the user-friendliness, safety and longevity of your products based on precise, data-supported findings.
Our range of services
We support you from the initial idea to market launch and beyond.
01
First workshop
In an initial workshop, we analyse your product idea together, check the approval requirements and develop a software concept. At the end, you will receive a well-founded assessment of feasibility, costs and resources, including an initial technical and regulatory evaluation. This allows you to concentrate on the idea and internal implementation. Our experts are at your side throughout the entire process.
02
Development phase
During the development phase, we support you with software development, cyber security, usability, authorisation and communication with authorities. We ensure that all regulatory requirements are met and help to develop training concepts for end users.
03
Market launch
We minimise delays in the approval process during the market launch. We support you with country-specific requirements, documentation and change management. This saves you time and money and brings your product to market faster.
04
After the launch
We are also your partner after the launch. Through regular software updates, we optimise your product, ensure cyber security and facilitate approval management. This keeps your solution secure and future-proof.
I will answer your questions.
Elisa Cosco
Business Development Manager
Fragen?
Fabiola Hartung-Linz
Business Development Manager MedTech