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| Course Title Click on a title to view course description | ID | Duration | Basic | Premium | Purchase |
|---|---|---|---|---|---|
| Biological Evaluation of Medical Devices: A Risk-Based Approach | N134 | 63 mins | € 205.00 | € 158.00 | |
| Introduction to Process Validation | N135 | 75 mins | € 243.00 | € 183.00 | |
| Validation of Ethylene Oxide Sterilization of Medical Devices | N186 | 53 mins | € 172.00 | € 129.00 |
| Course Title Click on a title to view course description | ID | Duration | Basic | Premium | Purchase |
|---|---|---|---|---|---|
| Biocompatibility of Medical Devices | N188 | 50 mins | € 166.00 | € 125.00 |
| Course Title Click on a title to view course description | ID | Duration | Basic | Premium | Purchase |
|---|---|---|---|---|---|
| Complaint Handling and Reporting Process for Medical Devices | 141 | 65 mins | € 211.00 | € 158.00 | |
| Demarcation of Medical Devices to Other Products | 75 | 60 mins | € 195.00 | € 146.00 | |
| Pre-Market Approval for Medical Device in China | N139 | 53 mins | € 172.00 | € 129.00 | |
| The European Medical Device New Regulation 2017/745 | N180 | 330 mins | € 925.00 | € 694.00 | |
| The ASEAN Common Submission Dossier Template (CSDT) and Its Contents | N203 | 70 mins | € 220.00 | € 165.00 | |
| Labeling Requirements for Medical Devices | |||||
| Labeling Requirements for Medical Devices in Europe | N133 | 87 mins | € 283.00 | € 212.00 | |
| Electronic Instructions for Use of Medical Devices in the European Union | N143 | 50 mins | € 167.00 | € 125.00 | |
| Course Title Click on a title to view course description | ID | Duration | Basic | Premium | Purchase |
|---|---|---|---|---|---|
| Understanding Clinical Evaluation for Notified Body and Regulatory Professionals | |||||
| Clinical Evaluation Report: Review for Regulatory Professionals | 107 | 70 mins | € 308.00 | € 231.00 | |
| Data from Prospective Clinical Investigation for CE-Mark: Review for Regulatory Professionals | 122 | 95 mins | € 418.00 | € 314.00 | |
| Including an IVD on the Australian Register of Therapeutic Goods | |||||
| IVD Australia: Basics for including an IVD on the ARTG | N150 | 44 mins | € 194.00 | € 145.00 | |
| IVD Australia: The Use of GMDN Codes for IVDs in Australia | N151 | 45 mins | € 198.00 | € 149.00 | |
| IVD Australia: Making Applications for Inclusion on the ARTG | N152 | 33 mins | € 145.00 | € 109.00 | |
| IVD Australia: Obtaining a TGA Conformity Assessment Certificate for IVD devices | N153 | 40 mins | € 176.00 | € 132.00 | |
| IVD Australia: Fees for Including an IVD Device on the TGA or ARTG | N154 | 43 mins | € 189.00 | € 142.00 | |
| Course Title Click on a title to view course description | ID | Duration | Basic | Premium | Purchase |
|---|---|---|---|---|---|
| ISO 13485:2016 - Medical Devices Quality Management Systems Requirements for Regulatory Purposes | 196 | 183 mins | € 403.00 | € 303.00 | |
| Overview of US FDA Quality System Regulation | 118 | 75 mins | € 330.00 | € 248.00 |
| Course Title Click on a title to view course description | ID | Duration | Basic | Premium | Purchase |
|---|---|---|---|---|---|
| How to Navigate Through the ISO 13485 Certification Process | 195 | 44 mins | € 194.00 | € 145.00 | |
| Preparing Successfully for a US FDA Medical Device Inspection | 215 | 109 mins | € 365.00 | € 274.00 | |
| Internal Auditor Training for Medical Device Manufacturers | 209 | 214 mins | € 717.00 | € 538.00 | |
| Project Management of Medical Device Development | N136 | 85 mins | € 374.00 | € 281.00 |
| Course Title Click on a title to view course description | ID | Duration | Basic | Premium | Purchase |
|---|---|---|---|---|---|
| Introduction to Medical Devices from Idea to Market | |||||
| The Lifecycle of Medical Devices from Idea to Market | 159 | 42 mins | € 136.00 | € 102.00 | |
| Course Title Click on a title to view course description | ID | Duration | Basic | Premium | Purchase |
|---|---|---|---|---|---|
| Team Building | 93 | 100 mins | € 429.00 | € 322.00 | |
| Effective Time Management | N148 | 176 mins | € 664.00 | € 531.00 |
| Course Title Click on a title to view course description | ID | Duration | Basic | Premium | Purchase |
|---|---|---|---|---|---|
| CMDA Clinical Evaluation - Mock Exam | N131 | 90 mins | € 90.00 | € 90.00 |