Standards, rules, regulations: The medical sector certainly has plenty of challenges in store for new medical products. As your certified partner of choice, we have the know-how to rise to the occasion. We accompany you from the beginning to the approval with this motto in mind: What we advise, we can also provide.
Regulatory consulting in connesction with MDR, IVDR and FDA
The transition to MDR and IVDR is putting even more and bigger hurdles in device manufacturers’ path. Born of many years’ experience developing medical technology and meeting regulatory demands, our advice is rooted in real-world insights. Complying with complex regulations while assuring efficient development is a balancing act we have perfected in the last 25 years.
Support for ISO 1497:2019 – compliant risk management
Risk management is crucial in medical engineering. The challenge for device manufacturers is to quantify the risks inherent in their medical devices in relation to the benefits they bring to patients and doctors. Our support for your efforts to mitigate risk starts with the development phase and carries over to every stage of your risk analysis, assessment, and management. We provide
Support for risk management in compliance with ISO 14971: 2019
Advice on risk policy and risk acceptance
FTA to assess the system architecture
Documentation and link to development
Consulting on Quality Management according to ISO 13485:2016
When it comes to medical devices, patient and user safety is paramount. As an ISO 13485-certified engineering partner, we know all about the requirements a quality management system has to satisfy to increase the safety of a medical device. Benefit from our wide-ranging services. Call on us to help you rapidly roll out a lean, standards-compliant quality management system and develop an advanced end-to-end system tailored to your needs using
The SPICE medical evaluation model
Templates and artifacts for implementation
Consulting to cover cyber security, usability engineering and software development
Whatever you may need – advice on conventional software development, method-based support for usability engineering, or holistic cyber security consulting services – our engineers are here to deliver the goods. Capitalize on their knowledge of methods, technology, and regulatory affairs. Take advantage of the insights born of more than 20 years’ experience in standards-compliant system and software development for medical devices. Call on us for
Threat and vulnerability analyses for medical devices
Security concepts and definition of protective measures
Interpret specifications for standards, including templates
The MDR has tightened up the requirements for the post-market phase. Mandatory tasks include creating a standards-compliant PMS plan, generating reports, and setting up a vigilance system. Our support in all matters related to the monitoring of your medical device on the market is yours for the asking, including
MDR-compliant post-market surveillance to ISO TR 20416:2020
PMS, PMCF, and vigilance systems
Managing and documenting development processes in real time
Rigorous standards in medical engineering make continuous monitoring on applications throughout their lifecycle a must-have. Application lifecycle management (ALM) tools serve to manage documents and development processes to enable seamless traceability for the system development effort. Let us help you digitalize your workflows and come up with a solution tailored to fit your needs. And if you want to manage QM documents with Polarion, that will not be a problem.
Risk management – typical pitfalls in the course day-to-day development work
Ultrasound devices, surgical robots, apps for monitoring blood glucose levels – medical products are all beneficial to humans regardless of their complexity. But practically they also entail risks for patients, users, or third parties. Minimizing risks while maximizing benefits is a matter of striking an acceptable balance. So how can development help achieve the best possible risk-benefit ratio?
Advice rooted in real-world experience A safe, secure journey to a medical product
Digitalization is the driving force behind innovations in medical technology. We not only develop components and full-fledged solutions; we can also advise you on new business models and technologies that will gear your products up to get them connected. Rest assured, we will be there for you throughout the entire development process.