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Final Safety Testing

Safety testing is the final requirement for submittal of regulatory materials and while the task list seems extensive, it is important to understand the following:

  • Full performance testing has already been completed, so we understand exactly how the device performs so there may be very few, if any issues with safety testing.

  • Much of the risk analysis section of the safety testing has already been completed by our own Allison Lehman and Charlie McGill.  Our culture has been to always be our own experts first.  No exception here.

  • The testing will now include our device designed to be self applied and will require a few adjustments in materials such as Instructions for Use etc, to be completed by our team.

Concrete

1.

Risk Management File and Labeling (IEC 60601-1, IEC 0601-1-2, IEC 60601-1-11, IEC 60601-2- 10)

Concrete

2.

Product Design Review (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10 requirements)

Concrete

3.

EMC Test Plan (IEC 60601-1-2 requirements)

Concrete

4.

Software Documentation (PEMS and IEC 62304 requirements)

Concrete

5.

Usability Engineering Documentation (IEC 60601-1-6 and IEC 62366 requirements)

Concrete

6.

Description of Testing/ Evaluation Tasks and Testing

Concrete

7.

Gap Analysis of all Risk and Testing (IEC 60601-1, IEC 0601-1-2, IEC 60601-1-11, IEC 60601-2- 10)

Concrete

8.

Finalize Deliverables - (Hold a closing meeting to present) 

Follow our progress as we check the boxes off the list above