Medical consulting born of experience

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.

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

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

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

Cyber security

• Threat and vulnerability analyses for medical devices
• Security concepts and definition of protective measures
• Security tests
• Advice on security engineering processes

IEC 62366-1:2015+COR1:2015+A1:2020-compliant usability engineering

• Determine use cases from the user’s perspective
• Identify and minimize risks for the user

IEC 62304:2006+A1:2015-compliant software lifecycle

• Interpret specifications for standards, including templates
• Tool support

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