Module 12 Presentations

29/01/2024

Classification & Pathways

Class I or II – Exempt

Class I or II – Not Exempt

Class III

Self-certified

PMA

510k

[+/- Regulatory controls]

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Walk in the park

Half Marathon

Exempt

510k

Marathon

Iron man

De Novo PMA

Credit: Michelle Lott -LeanRAQA

©Copyright Easy Medical Device GmbH

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