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
Adobe Acrobat Dokument 954.8 KB
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 Significant Change Decision Chart.pd
Adobe Acrobat Dokument 2.3 MB
MDR Conformity Assessment Procedures
This poster provides an overview of the different MDR Conformity Assessment Procedures per product class.
MDR Conformity Assessment Procedures.pdf
Adobe Acrobat Dokument 1.1 MB
MDR Technical Documentation
This poster shows you the necessary contents of a technical documentation according to Annex II of the MDR.
Technical Documentation Structure per MD
Adobe Acrobat Dokument 940.0 KB