MedSysCon Medizintechnik GmbH

Impressum: https://www.medsyscon.com/impressum/

With employees & partners having 20+ years of experience, we are offering consulting and support in the following areas within Medtech:
• Quality Management, including audits according to ISO 13485: 2016
• Risk Management according to ISO 14971
• Regulatory Affairs
• Medical Device Regulation (MDR)
• Software As a Medical Device (SaMD) according to IEC 62304
• Usability Engineering according to IEC 62366
• International Project Management
Our portfolio covers consulting, management of complex projects and interim management. It is our business to meet your special needs and to offer ideal solutions. We support you at strategic, operational and managerial level.

Company’s 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