MedSysCon Medizintechnik GmbH

medical devices

About

MedSysCon Medizintechnik GmbH is a consulting company based in Freiburg im Breisgau, Germany, specializing in medical engineering. They provide expert services in quality management and regulatory compliance for medical devices, offering tailored solutions that span the entire product lifecycle, from initial concept to market approval. Their focus is on helping clients navigate complex international quality standards and regulatory requirements, including the Medical Device Regulation (MDR). The company’s core competencies include consulting on quality management systems, regulatory affairs, clinical evaluation, and usability issues. MedSysCon aims to enhance product quality and ensure compliance, addressing challenges such as usability-related incidents that can lead to recalls. Their experienced team works closely with medical device manufacturers and developers, providing innovative solutions to support regulatory readiness and risk management. MedSysCon is dedicated to fostering partnerships that yield sustainable outcomes for their clients in the medical technology sector.

Technologies

Outlook Microsoft Office 365 WordPress.org Bootstrap Framework Mobile Friendly Apache Google Tag Manager Shutterstock Remote

Keywords

quality management risk management medical software design control usability ce marking fda regulatory affairs consulting medical device regulation mdr technical documentation iso 13485 iso 14971 iec 62304 iec 62366 udi eudamed software validation medical devices clinical evaluation medical equipment manufacturing gebrauchstauglichkeit medizintechnik softwareentwicklung nach iec 62304 compliance medizinsoftwareentwicklung risikobewertung medizinprodukte qualitätsaudit product development

Location

56 Hildastrasse, Freiburg, Baden-Wuerttemberg, Germany, 79102

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