Use HMV updates to reassess the chances of success of paused applications: It is always worthwhile to take a look at the changes.
Here we inform you about events and news on reimbursement and regulatory issues.
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FDA announces fee increases for 2022
The U.S. Food and Drug Administration (FDA) announced fees increase for 2022. The fees change annually. Affected are submissions including but not limited to: 510(k) Premarket Notifications (PMN), Premarket Approvals…
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Standard in Focus: DIN EN ISO 80601-2-70:2021-06 Medical Electrical Equipment
Medical electrical equipment
Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
New Standards and Standard Projects in July 2021
DIN CEN ISO/TS 5499 (Project), DIN EN 00205320 (Project), ISO/AWI 8549-2 (Project), DIN EN ISO 10993-18/A1 (Project), DIN EN 15194/A1 (Project), DIN EN ISO 81060-3 (Draft), DIN EN ISO 80601-2-70, DIN 58950-2, DIN 58950-3. DIN EN ISO 80601-2-67, DIN EN ISO 80601-2-69
Enforcement of the MPG and Random Product Testing
Testing must be well planned and test samples properly configured. Discuss your goals with us and test once but properly, then neither random samples, nor nationally deviating requirements will be a hurdle for you.
Standard in Focus: DIN EN ISO 15223-1:2020-04 – Draft
This month, DIN EN ISO 15223-1:2020-04: Medical devices (draft) was published
