Meeting the testing thresholds for 60601-1 is a presumption of conformity with the MDR (Medical Device Reporting) essential requirements and aligns with the FDA recognized consensus standards demonstrating basic safety. We at DCT can provide all manufacturers of medical devices with expert consulting and testing services related to the medical electrical equipment safety standard, IEC 60601, and its related risk management ISO 14971, essential performance (EP), usability engineering IEC 62366-1, and software development life cycle Clause 14 and IEC 62304. 

Our engineering team and network of industry professionals will assist you with testing and troubleshooting as well as the preparation of insulation diagrams and defining any manufacturers who may have different EP requirements.