Insider tips to speedup certification by MedicalRegs.com

Insider Tips To Speed-Up Your Product Safety Certification Ideally, you should design your device to meet the applicable standards. Pre-certification review Double-check your device construction and components to applicable standards before submitting for formal certification. There's a 90% chance that at least one area will fail to meet the requirements. Documentation to submit: Isolation diagram. instructions, schematics: Electrical, pneumatic & hydraulic, mechanical drawings, critical components list, and label artwork Keep it organized Provide a secure link to your documentation rather than email attachments or piece-by-piece emails. Create folders to organize documents. essential performance List the essential performance of your device as this will be the pass or fail criteria for some tests. Critical components list Include components in primary, hazardous secondary voltage, and safety circuits. Also, include polymeric parts used for an electrical enclosure, insulation including PCB, and label materials. A "BOM" is Insufficient Create a spreadsheet for the critical components identifying the following: Manufacturer, model, & specifications. Attach proof of certification/approval. Component Conditions of Acceptability Make sure you use the components based on conditions. Component test reports will identify these conditions. PCB / PWB Include certification info. to UL-94 flammability rating or equivalent international standard. Include material type (i.e., FR4), CTI and conformal coating. Provide PCB trace voltage map. Provide unpopulated PCB sample. label material Provide label material information and approval. Some test labs are picky about this. The label material should be compatible with the device surface. isolation / insulation diagram The diagram will show where the patient and user contacts are on the device and will determine the insulation requirements, spacing, and test voltages. Instructions Submit quick guides, IFU, maintenance, and servicing instructions. It's okay if initially in draft form. rmf Submit RMF per IEC 60601-1 in accordance with ISO 14971. Collateral Standards Include documentation for usability, home healthcare, software, etc. if part of your certification requirements. construction review The test lab engineer will dissect your device and compare its construction to the requirements clause by clause. At this stage, all required information should be in front of the test lab engineer. Keep the momentum going by not having to stop so the engineer can request for additional information. If the test lab engineer has to stop while waiting for information, he/she will jump to another project. An engineer may have five projects going on at the same time. You will have to wait for your turn again. testing Depending on failures discovered during construction review, the testing phase can begin or delayed. test report Once the assessment is successful, a test report will be issued to you. conclusion The small amount of time you spend organizing your documents and providing needed information will benefit you by avoiding unnecessary delays.