USA - FDA
510(k) Basics
In this video basics of the FDA 510(k) Premarket Notification are explained:
- Types of 510(k) Submissions
- Legally Marketed Device / Predicate Device
- Substantial Equivalence & Decision Making Flowchart
510(k) - Timeline & Costs
This video explains the following important requirements:
- How much will the 510(k) submission cost ?
- How long does a 510(k) take ?
- How do I plan my clearance time realistically ?
EU MDR - 2017/745
Roadmap to Class I MDR Compliance
Roadmap to Class I MDR Compliance
This Roadmap shows the most important steps to achieve MDR Compliance based on MDCG 2019-15
This Roadmap shows the most important steps to achieve MDR Compliance based on MDCG 2019-15
MDR Significant Change Decision Chart
This Change Decision Chart enables you to evaluate whether your product change is 'significant' in terms of Article 120 of the MDR.
MDR Conformity Assessment Procedures
This poster provides an overview of the different MDR Conformity Assessment Procedures per product class.
MDR Technical Documentation
This poster shows you the necessary contents of a technical documentation according to Annex II of the MDR.