Washington Laboratories has extensive experience in Medical Device Testing and Evaluation.
Medical devices are subject to many regulatory standards from general requirements for basic safety and essential performance (60601-1) with inclusion of several collateral standards dealing with operational characteristics (e.g. 60601-1-2 for EMC; 60601-1-11 for home medical, etc.) and vertical standards dealing with specific aspects of the device (particular standards often referred to as -2 standards). Test and evaluation of the applicable requirements stem from Edition 3 (currently in effect for most regions) with a risk based review to assess applicability of the standard and to identify areas not covered by the standards.
The evaluation process starts with the manufacturer by developing the risk analysis based on ISO 14971. The risk analysis results in a Risk Management File (RMF) used throughout the test and evaluation process. The risk analysis and supporting processes are called out in ISO 14971. Submittal of the RMF with the test sample and associated critical component approvals to the test lab is essential to support the evaluation. This information determines many of the acceptance criteria elements and defines specific items that require evaluation – just consider that in the risk analysis the evaluation is used to assess acceptability.
After the test and evaluation work completes, the RMF is updated to show acceptability of those analysis elements that were pending compliance to verify acceptability of the risk. This process places the overall evaluation process into an interactive evaluation and update for a few requirement elements but generally this is a one-time interaction to resolve this open element.
Scope of Services
We provide test and evaluation services for many of the medical standards and with affiliations throughout the world, we can make arrangements to support your product approvals as desired. Depending on the product, evaluation reports may be accepted by the country or may require specific evaluation by an in-country laboratory. We also have resources outside of the evaluation process to support your product design to achieve resolution of compliance concerns and risk evaluation.
Contact us with your questions or to discuss how we can support your product approval.
Some Specifics
IEC 60601-1-11 for Home Medical
