The MedTech market demands ever shorter innovation cycles, but strict regulatory requirements such as MDR, ISO 13485 and IEC 62304 set clear limits to ensure patient safety and product quality. Companies must find a balance between agility and compliance in order to remain competitive.
The hurdles for software-based medical devices are high: development processes must be structured, auditable and traceable. With its guideline 5702, the VDI has set clear specifications for medical device software – Medical SPICE.
Unsuitable processes cause high costs due to delays and can even jeopardize market access.
Fleckner + Simon supports medical technology companies in overcoming these challenges. With our expertise in standard-compliant software development, optimized development processes and Medical SPICE, we help you to bring innovative medical technology products to market quickly and safely.
Challenges
1. standard-compliant software development
Medical technology software is more than just a product feature – it is a medical device itself. Faulty or unsafe software can have serious consequences for patients and users. For this reason, development is subject to strict specifications, in particular IEC 62304, which regulates the life cycle of medical software.
Fleckner + Simon has extensive experience in standard-compliant software development.
We rely on integrated ALM and test tools to create end-to-end processes for requirements management, risk analysis, verification and validation. In this way, we ensure that your software not only meets the requirements, but is also developed efficiently and without unnecessary friction losses.
Our services
We support companies in this:
integrate the regulatory requirements into the development process right from the start,
software securely, efficiently and traceably,
to ensure complete documentation and traceability.
Challenges
2. reduction of time-to-market
Medical technology is an innovation-driven market. Long development times increase the risk of being left behind by the competition, often due to long validation cycles and regulatory hurdles.
Fleckner + Simon optimizes your development processes and significantly shortens the time-to-market without compromising on quality.
Through structured processes, we help you to overcome regulatory hurdles at an early stage and avoid expensive corrections – so you can bring your product to market more quickly and safely.
Our services
Our measures include:
Automation of test and validation processes to avoid delays,
Establishment of end-to-end configuration and change management in order to control iterations efficiently,
Smart integration of Continuous Integration (CI) and Continuous Deployment (CD) to deliver market-ready software faster.
Challenges
3. medical SPICE
In order to develop successful and safe medical products in the long term, companies need a mature and reliable software quality management system. This is where Medical SPICE comes in – a maturity model that helps to measurably improve development processes and systematically implement regulatory requirements.
As experts in process evaluation and optimization, F+S supports medical technology companies in successfully implementing Medical SPICE.
Medical SPICE creates measurable transparency in software development. Companies with structured quality management can be audited more quickly, reduce error costs and accelerate approval.
Our services
Successful implementation of Medical SPICE:
Gap analyses and assessments to determine the current maturity level of software development,
Definition and implementation of improved processes to increase efficiency and compliance,
Training and coaching of teams so that Medical SPICE is practiced sustainably.
"Development projects are also becoming increasingly complex and demanding in the medical sector. They must comply with standards and still be realized "just in time". That requires special knowledge and a highly efficient team. We offer you both."
Daniel Luscher
Team Lead Software Engineering