We have helped our clients set up efficient systems that facilitate getting FDA clearance and the CE mark.
The documents we develop and the work we do follow industry standards. This leads to better and more robust designs and documentation. We also follow many IEC and ISO standards and FDA regulations and guidance in our work. Below are just a few examples of the regulations and standards we follow.
FDA RegulationsPremarket Notification 510(k)
Premarket Approval (PMA)Investigational Device Exemption (IDE)Quality System (QS) regulationLabeling requirementsMedical Device Reporting (MDR)
IEC Standards 60601 (Safety)60812 (FMEA)61025 (FTA)62304 (Software Life Cycle)62366 (Usability)60904 (Photovoltaic I-V)
ISO Standards 9001 (Quality Mgmt Sys)10940 (Fundus Camera)15004 (Ophthalmic Instr.)13485 (Med. Quality Mgmt Sys)14971 (Risk Mgmt)21649 (Needle Free Injector)
IEEE Standards 730 (SQA)828 (Conf Mgmt)830 (SRS)1008 (Unit Test)1016 (SDD)1233 (SyRS)29148 (Req. Eng.)