2 Responses

  1. Michael Cejnar
    Michael Cejnar at |

    Brilliant very useful article.
    I can confirm the gap route works.
    I have a small company with Class 2b ME with CE and FDA and indeed we did an internal gap analysis even for Ed2 to Ed3 and found a Californian Test Lab to review our tests, redo some tests themselves and certify the gap. BSI was happy.
    Gap to 3.1 we did entirely internally, and Ed4.0 via a cost-effective pre-compliance lab.
    We are in 60 countries, but withdrew from Canada due to MDSAP astronomical costs and rolled our eyes at Brazil’s requirement for establishment inspections and as you say, local 60601 re-testing.

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