MedSysCon offers tailor-made scalable solutions for international quality and regulatory compliance. Our comprehensive services cover the overall product lifecycle from the idea to the approved product.
We set the focus on effective integration of new quality requirements in value-added processes supporting the consistent exploitation of existing potential for optimization.
MedSysCon stands for reliable, high-quality consulting services in the medical device field. Our strength origins in experience, expertise and passion for high-quality solutions. We are passionate about supporting you to finish your most challenging projects. We are driven by excellence.
We help you to grow your business. We support you in the creation of higher value through higher quality based on best-in-class compliance consultation.
That’s what you can expect:
- Professional consulting, excellent quality and innovative approaches
- Objective-driven solutions that fully meet your specific needs
- A close working partnership that will result in sustainable and measurable outcome
- Best-in-class consultants with broad industrial exposure and experiences
Are you well prepared for MDR?
Are you well prepared regarding the new requirements of the MDR? Your company wants to approach new markets? We will support you to answer these questions and help you to find a smooth way for getting your medical devices market approval.
More and more incidents caused by usability issues.
A survey of the German Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) has shown that at 42 percent of the incidents are based on usability issues of medical devices. 70% of FDA recalls of software products are due to usability problems.
Clinical evaluation is required for each medical device.
The clinical evaluation is required for each medical device regardless of its classification. The clinical evaluation plays a major role when it comes to development and market introduction of medical devices.