January 30, 2020
In order to prevent delays in your project (starting the project to completing the project), we have outlined the top-five items that cause delays and what can be done to prevent them from being an issue.
- Lack of samples and/or correct samples
- Without the necessary samples, the project evaluation and testing cannot be started.
- Operating and setup instructions are necessary to start the project on time and get the sample functioning.
- Accessories must be provided even when samples are available to avoid additional delays.
- In many instances, testing can be destructive to the unit. Extra samples/parts are necessary to report the sample and keep the testing on track. Since some testing can be destructive, a discussion on extremely expensive parts should be had to determine if other options are available (example: a nonfunctioning sample for drop test).
- Instruction Manual
- The standard used (base, collateral and particular) provides very clear guidance on items that must be in the manual. Guidance on the location of each items, per clause 7.9, will save time during the manual review.
- A complete manual available at the start of the project. Without a manual the risk increases of tests being conducted incorrectly since items were not defined or changed in the printed manual.
- Risk management not complete/missing items
- An IEC 60601 project cannot be completed without a Risk Management File addressing specific items required by the standard.
- In order to assist in understanding what is expected in the Risk Management file based on a specific clause, OD-2044 (provided by the CB Scheme) provides guidance on questions the RM should address.
- In order to provide more guidance on the required Risk Management items, please see the RM Webinar available at the following link https://www.ul.com/events/recorded-webinar-10-most-common-mistakes-made-during-risk-analysis-medical-devices-according
- Software documentation
- Software used for basic safety/essential performance/software failure creates an unacceptable risk and is to be evaluated to Clause 14 and parts of IEC 62304 (4.3, 5, 7, 8 and 9)
- In order to comply with 62304 and Clause 14, the software validation needs to be completed.
- To show compliance with Clause 14 and IEC 62304, the output of the software process must be reviewed.
- Samples of the complete label is required to show compliance for durability and legibility. Since label material, color and ink can affect the legibility, actual labels are necessary to run the testing.
To discuss the items above or other items with our staff, please contact us today.