| Clinical Evaluation |
| Course Title | ID | Duration | Level | Basic | Premium | PDF | Purchase |
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| Clinical Project Management Complete 10 course Suite | 95 | 425 mins | | € 1317.00 | € 1044.00 |  | Buy Now |
| Course 1: Objectives and Setup of a Clinical Trial | 97 | 35 mins | | € 160.00 | € 120.00 |  | Buy Now |
| Course 2: The Clinical Trial Master Plan | 98 | 50 mins | | € 200.00 | € 150.00 |  | Buy Now |
| Course 3: Budget and Timelines Planning | 99 | 100 mins | | € 400.00 | € 300.00 |  | Buy Now |
| Course 4: Team Resources | 100 | 50 mins | | € 200.00 | € 150.00 |  | Buy Now |
| Course 5: Tracking and Reporting Rules | 101 | 25 mins | | € 100.00 | € 75.00 |  | Buy Now |
| Course 6: Project Guidelines | 102 | 30 mins | | € 120.00 | € 90.00 |  | Buy Now |
| Course 7: Managing Ongoing Clinical Investigations | 103 | 20 mins | | € 80.00 | € 60.00 |  | Buy Now |
| Course 8: Compliance Management | 104 | 40 mins | | € 160.00 | € 120.00 |  | Buy Now |
| Course 9: Effective Communication | 105 | 50 mins | | € 200.00 | € 150.00 |  | Buy Now |
| Course 10: Project Close Out and Clinical Report | 106 | 30 mins | | € 120.00 | € 90.00 |  | Buy Now |
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| Safety Reporting Requirements 2 course Suite | 79 | 45 mins | | € 106.00 | € 80.00 |  | Buy Now |
| Course 1: National Requirements Europe | 82 | 25 mins | | € 74.00 | € 55.00 |  | Buy Now |
| Course 2: National Requirements US | 90 | 20 mins | | € 59.00 | € 44.00 |  | Buy Now |
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| US Bioresearch Monitoring 3 Course Suite | 142 | 461 mins | | € 1046.00 | € 784.00 |  | Buy Now |
| Course 1: US FDAs BIMO Compliance Program | 143 | 54 mins | | € 165.00 | € 123.00 |  | Buy Now |
| Course 2: IDE Sponsor Obligations | 150 | 180 mins | | € 549.00 | € 411.00 |  | Buy Now |
| Course 3: IDE Investigator Obligations | 155 | 190 mins | | € 594.00 | € 446.00 |  | Buy Now |
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| Clinical Evaluation for Market Approval | 125 | 188 mins | | € 616.00 | € 462.00 |  | Buy Now |
| Course 1: Process and Regulatory Background | 116 | 80 mins | MMDP | € 328.00 | € 246.00 |  | Buy Now |
| Course 2: Literature Review | 120 | 50 mins | MMDP | € 205.00 | € 154.00 |  | Buy Now |
| Course 3: Producing a Clinical Evaluation: Step by Step Primer | 124 | 58 mins | MMDP | € 238.00 | € 178.00 |  | Buy Now |
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| ISO 14155: In Depth Review | 68 | 195 mins | | € 594.00 | € 357.00 |  | Buy Now |
| Course 1: Scope of the ISO 14155:2011 | 61 | 20 mins | | € 61.00 | € 46.00 |  | Buy Now |
| Course 2: ISO 14155:2011 - Ethical Considerations | 62 | 20 mins | | € 61.00 | € 46.00 |  | Buy Now |
| Course 3: ISO 14155:2011 - Clinical Investigation Planning | 63 | 20 mins | | € 61.00 | € 46.00 |  | Buy Now |
| Course 4: ISO 14155:2011 - Clinical Investigation Conduct | 64 | 40 mins | | € 122.00 | € 91.00 |  | Buy Now |
| Course 5: ISO 14155:2011 - Clinical Investigation Close Out | 65 | 20 mins | | € 61.00 | € 46.00 |  | Buy Now |
| Course 6: ISO 14155:2011 - Responsibilities of Sponsor | 66 | 45 mins | | € 137.00 | € 103.00 |  | Buy Now |
| Course 7: ISO 14155:2011 - Responsibilities of Principal Investigator | 67 | 30 mins | | € 91.00 | € 69.00 |  | Buy Now |
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| Auditing Medical Device Clinical Investigations | 216 | 160 mins | | € 449.00 | € 336.00 |  | Buy Now |
| Course 1: Fundamentals of Auditing Medical Device Clinical Investigations | 217 | 36 mins | CMDP | € 110.00 | € 82.00 |  | Buy Now |
| Course 2: Sponsor/Third Party Audits of Clinical Investigation sites | 218 | 66 mins | | € 201.00 | € 151.00 |  | Buy Now |
| Course 3: Auditing the Clinical Research Organization and the Sponsor | 219 | 82 mins | CMDP | € 250.00 | € 187.00 |  | Buy Now |
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| EU Clinical Investigation Agreements | 153 | 80 mins | | € 195.00 | € 146.00 |  | Buy Now |
| Course 1: Understanding EU Clinical Investigation Agreements | 111 | 40 mins | | € 122.00 | € 91.00 |  | Buy Now |
| Course 2: Negotiating EU Clinical Investigation Agreements | 112 | 40 mins | | € 122.00 | € 91.00 |  | Buy Now |
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| Medical Device GCP for Investigators | 187 | 210 mins | | € 120.00 | € 100.00 |  | Buy Now |
| Course 1: Introduction to Medical Devices | 193 | 52 mins | CMDA | € 104.00 | € 78.00 |  | Buy Now |
| Course 2: How to Qualify for Medical Device Clinical Investigations | 200 | 32 mins | CMDA | € 86.00 | € 65.00 |  | Buy Now |
| Course 3: Ethics and Legal Processes for Medical Device Clinical Investigations | 212 | 25 mins | CMDA | € 76.00 | € 57.00 |  | Buy Now |
| Course 4: Initiation of the Clinical Investigation | 202 | 30 mins | CMDA | € 86.00 | € 65.00 |  | Buy Now |
| Course 5: Clinical Investigation Conduct and Reporting | 204 | 51 mins | CMDA | € 116.00 | € 87.00 |  | Buy Now |
| Course 6: Clinical Investigation Close out or termination | 206 | 23 mins | CMDA | € 60.00 | € 45.00 |  | Buy Now |
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| Safety Related Committee Establishment | 126 | 180 mins | | € 576.00 | € 432.00 |  | Buy Now |
| Course 1: Clinical Events Committee (CEC) Establishment | 114 | 90 mins | CMDP | € 360.00 | € 270.00 |  | Buy Now |
| Course 2: Data Safety & Monitoring Board (DSMB) Establishment | 127 | 90 mins | CMDP | € 360.00 | € 270.00 |  | Buy Now |
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| Effective Monitoring of Medical Device Clinical Investigations | 57 | 720 mins | | € 1517.00 | € 1138.00 |  | Buy Now |
| Course 1: History of Good Clinical Practice (GCP) | 41 | 15 mins | CMDA | FREE | FREE |  | Buy Now |
| Course 2: Introduction to Good Clinical Practice | 42 | 45 mins | CMDA | € 90.00 | € 68.00 |  | Buy Now |
| Course 3: Introduction to Medical Device and Clinical Investigation Planning | 43 | 45 mins | CMDA | € 133.00 | € 100.00 |  | Buy Now |
| Course 4: The Clinical Investigation Plan | 44 | 45 mins | CMDA | € 133.00 | € 100.00 |  | Buy Now |
| Course 5: The Informed Consent Process | 45 | 45 mins | CMDA | € 133.00 | € 100.00 |  | Buy Now |
| Course 6: Ethics Committee(EC) / Institutional Review Board Requirements | 46 | 35 mins | CMDA | € 103.00 | € 78.00 |  | Buy Now |
| Course 7: Selecting Investigation Sites | 47 | 45 mins | CMDA | € 133.00 | € 100.00 |  | Buy Now |
| Course 8: Initiation Visit | 48 | 45 mins | CMDA | € 133.00 | € 100.00 |  | Buy Now |
| Course 9: Adverse Event Processes | 59 | 77 mins | | € 198.00 | € 148.00 |  | Buy Now |
| Course 10: The Periodic Monitoring Visit | 56 | 120 mins | CMDA | € 354.00 | € 266.00 |  | Buy Now |
| Course 11: Device Accountability | 50 | 20 mins | CMDA | € 59.00 | € 44.00 |  | Buy Now |
| Course 12: Deviations and Non-Compliance Handling | 51 | 15 mins | CMDA | € 44.00 | € 33.00 |  | Buy Now |
| Course 13: Source Document Verification | 52 | 30 mins | CMDA | € 89.00 | € 66.00 |  | Buy Now |
| Course 14: The Case Report Form Process | 53 | 45 mins | CMDA | € 133.00 | € 100.00 |  | Buy Now |
| Course 15: Visit Report Writing | 54 | 15 mins | CMDA | € 44.00 | € 33.00 |  | Buy Now |
| Course 16: The Close Down Visit | 55 | 15 mins | CMDA | € 44.00 | € 33.00 |  | Buy Now |
| Course 17: Overview of Data Management Plan and Query Process | 108 | 25 mins | CMDA | € 74.00 | € 55.00 |  | Buy Now |
| Course 18: Good Documentation Practices for Clinical Study Files | 96 | 45 mins | CMDA | € 133.00 | € 100.00 |  | Buy Now |
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| Designing a Strategic Clinical Investigation Plan | N20 | 167 mins | | € 557.00 | € 418.00 |  | Buy Now |
| Course 1: Format and Structure of the Clinical Investigation Plan | N140 | 42 mins | | € 132.00 | € 99.00 |  | Buy Now |
| Course 2: Design of the Clinical Investigation Plan | N141 | 90 mins | | € 454.00 | € 341.00 |  | Buy Now |
| Course 3: Clinical Investigation Plan Writing Process and Ensuring Compliance | N142 | 35 mins | | € 110.00 | € 83.00 |  | Buy Now |
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| Accelerating Successful Patient Recruitment | 119 | 70 mins | CMDA | € 207.00 | € 155.00 |  | Buy Now |
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| Clinical Data for Reimbursement | 157 | 57 mins | | € 233.00 | € 175.00 |  | Buy Now |
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| Basic Principles - DISCONTINUED, now course ID59 | 80 | 25 mins | ALL | € 74.00 | € 55.00 |  | Buy Now |
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| Reporting in Practice - DISCONTINUED, now course ID59 | 81 | 80 mins | | € 236.00 | € 177.00 |  | Buy Now |
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| Conducting studies using Electronic Data Capture | 109 | 30 mins | | € 91.00 | € 69.00 |  | Buy Now |
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| Directive 93/42/EEC and update 2007/47/EC: A review for clinical professionals (rev 1.2) | 60 | 60 mins | | € 183.00 | € 137.00 |  | Buy Now |
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| Importance of Clinical Investigator´s Brochure (IB) | 117 | 85 mins | CMDA | € 332.00 | € 249.00 |  | Buy Now |
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| IRB Review of Medical Devices | 148 | 153 mins | | € 452.00 | € 339.00 |  | Buy Now |
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| ISO 14155: 2011 – A Summary Review | 144 | 44 mins | | € 134.00 | € 100.00 |  | Buy Now |
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| ISO 14155 Version 2003 vs. 2011: Gap Analysis | 176 | 0 mins | | € 300.00 | € 105.00 |  | Buy Now |
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| Manage Data Release Consent in Post Market Studies | 226 | 31 mins | CMDA | € 58.00 | € 44.00 |  | Buy Now |
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| Conducting Medical Device Clinical Investigations in Switzerland | N138 | 34 mins | CMDP | € 104.00 | € 78.00 |  | Buy Now |
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| Combination Products |
| Course Title | ID | Duration | Level | Basic | Premium | PDF | Purchase |
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| Introduction to Combination Products in the USA | 213 | 62 mins | | € 242.00 | € 182.00 |  | Buy Now |
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| General Interest |
| Course Title | ID | Duration | Level | Basic | Premium | PDF | Purchase |
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| Applied Project Management | 71 | 328 mins | | € 775.00 | € 581.00 |  | Buy Now |
| Course 1: Project! | 72 | 23 mins | | € 68.00 | € 51.00 |  | Buy Now |
| Course 2: Project Stakeholders | 73 | 20 mins | | € 59.00 | € 44.00 |  | Buy Now |
| Course 3: Objectives and Arena | 74 | 30 mins | | € 89.00 | € 66.00 |  | Buy Now |
| Course 4: Visualizing | 84 | 10 mins | | € 30.00 | € 22.00 |  | Buy Now |
| Course 5: Project Planning | 85 | 40 mins | | € 118.00 | € 89.00 |  | Buy Now |
| Course 6: Project Organization | 86 | 35 mins | | € 103.00 | € 78.00 |  | Buy Now |
| Course 7: Project Environment | 87 | 30 mins | | € 89.00 | € 66.00 |  | Buy Now |
| Course 8: Risks and Opportunities | 88 | 30 mins | | € 89.00 | € 66.00 |  | Buy Now |
| Course 9: Project Realization | 89 | 60 mins | | € 177.00 | € 133.00 |  | Buy Now |
| Course 10: Project Leadership | 91 | 50 mins | | € 148.00 | € 111.00 |  | Buy Now |
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| Powerful Presentation Skills | 70 | 140 mins | | € 267.00 | € 200.00 |  | Buy Now |
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| Team Building | 93 | 100 mins | | € 390.00 | € 293.00 |  | Buy Now |
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| Health Economics & Reimbursement |
| Course Title | ID | Duration | Level | Basic | Premium | PDF | Purchase |
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| Introduction to EU Funding and Reimbursement of Medical Devices | 133 | 155 mins | | € 546.00 | € 409.00 |  | Buy Now |
| Course 1: Introduction to European F and R Systems | 134 | 40 mins | | € 118.00 | € 89.00 |  | Buy Now |
| Course 2: German Healthcare System | 135 | 35 mins | | € 103.00 | € 78.00 |  | Buy Now |
| Course 3: French Healthcare System | 136 | 22 mins | | € 88.00 | € 49.00 |  | Buy Now |
| Course 4: UK Healthcare System | 137 | 35 mins | | € 103.00 | € 78.00 |  | Buy Now |
| Course 5: Italian Healthcare System | 138 | 20 mins | | € 59.00 | € 44.00 |  | Buy Now |
| Course 6: Developing an EU Reimbursement Strategy for a Medical Device | 139 | 40 mins | | € 118.00 | € 89.00 |  | Buy Now |
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| The Basics of US Private Payer Reimbursement for Medical Devices | 140 | 32 mins | | € 64.00 | € 48.00 |  | Buy Now |
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| Health Economic Evaluation of Medical Technologies | 115 | 65 mins | | € 322.00 | € 241.00 |  | Buy Now |
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| Reimbursement Strategy for Medical Devices in the US | 156 | 45 mins | | € 86.00 | € 64.00 |  | Buy Now |
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| Pre-Clinical |
| Course Title | ID | Duration | Level | Basic | Premium | PDF | Purchase |
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| Good Laboratory Practices & Biological Evaluation for Medical Devices | 110 | 70 mins | CMDA | € 213.00 | € 160.00 |  | Buy Now |
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| Understanding Software Validation | 227 | 54 mins | CMDA | € 211.00 | € 158.00 |  | Buy Now |
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| Biological Evaluation of Medical Devices: A Risk-Based Approach | N134 | 58 mins | | € 186.00 | € 144.00 |  | Buy Now |
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| Introduction to Process Validation | N135 | 75 mins | | € 221.00 | € 166.00 |  | Buy Now |
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| Standalone Software Under the Medical Devices Directives | N137 | 40 mins | | € 160.00 | € 120.00 |  | Buy Now |
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| Quality Assurance |
| Course Title | ID | Duration | Level | Basic | Premium | PDF | Purchase |
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| ISO 13485: Foundation and Basic Principles | 196 | 142 mins | | € 304.00 | € 228.00 |  | Buy Now |
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| How to Navigate Through the ISO 13485 Certification Process | 195 | 44 mins | | € 176.00 | € 132.00 |  | Buy Now |
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| Importance of Technical Standards in the Medical Device Sector | 185 | 72 mins | | € 213.00 | € 159.00 |  | Buy Now |
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| Overview of US FDA Quality System Regulation | 118 | 75 mins | | € 300.00 | € 225.00 |  | Buy Now |
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| Preparing Successfully for a US FDA Medical Device Inspection | 215 | 109 mins | | € 332.00 | € 249.00 |  | Buy Now |
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| Internal Auditor Training for Medical Device Manufacturers | 209 | 214 mins | | € 652.00 | € 489.00 |  | Buy Now |
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| Regulatory Affairs |
| Course Title | ID | Duration | Level | Basic | Premium | PDF | Purchase |
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| Navigating International Regulatory Systems | 152 | 528 mins | | € 1205.00 | € 903.00 |  | Buy Now |
| Course 1: Introduction to the US FDA | 76 | 25 mins | | FREE | FREE |  | Buy Now |
| Course 2: Hong Kong´s Regulatory System for Medical Devices | 186 | 72 mins | | € 219.00 | € 165.00 |  | Buy Now |
| Course 3: The Australian Regulatory System for Medical Devices | 113 | 110 mins | | € 325.00 | € 244.00 |  | Buy Now |
| Course 4: The European Union Regulatory System for Medical Devices | 145 | 175 mins | | € 525.00 | € 388.00 |  | Buy Now |
| Course 5: The Japanese Regulatory System for Medical Devices | 146 | 95 mins | | € 290.00 | € 217.00 |  | Buy Now |
| Course 6: The Singapore Regulatory System for Medical Devices | 191 | 51 mins | | € 155.00 | € 117.00 |  | Buy Now |
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| Risk Management for Medical Devices in the EU and US | 77 | 94 mins | | € 229.00 | € 172.00 |  | Buy Now |
| Course 1: ISO 14971: 2007 Review | 78 | 35 mins | | € 107.00 | € 80.00 |  | Buy Now |
| Course 2: Preparing Risk Management File & Which Techniques Apply | 83 | 24 mins | | € 73.00 | € 55.00 |  | Buy Now |
| Course 3: Integrating Risk Management into Your Quality Management System | 94 | 35 mins | | € 107.00 | € 80.00 |  | Buy Now |
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| Understanding Clinical Evaluation for Notified Body and Regulatory Professionals | 123 | 170 mins | | € 544.00 | € 408.00 |  | Buy Now |
| Course 1: Clinical Evaluation Report of Existing Data | 107 | 50 mins | | € 200.00 | € 150.00 |  | Buy Now |
| Course 2: Conduct of a Prospective Clinical Investigation | 122 | 120 mins | | € 480.00 | € 360.00 |  | Buy Now |
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| Labeling Requirements for Medical Devices | N21 | 202 mins | | € 493.00 | € 370.00 |  | Buy Now |
| Course 1: Labeling Requirements for Medical Devices in Europe | N133 | 87 mins | | € 257.00 | € 193.00 |  | Buy Now |
| Course 2: Electronic Instructions for Use for Medical Devices in the European Union | N143 | 45 mins | | € 152.00 | € 114.00 |  | Buy Now |
| Course 3: Labeling Requirements for Medical Devices in the US | N144 | 70 mins | | € 207.00 | € 155.00 |  | Buy Now |
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| Complaint Handling and Reporting Process for Medical Devices | 141 | 65 mins | | € 192.00 | € 144.00 |  | Buy Now |
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| Demarcation of Medical Devices to other Products | 75 | 60 mins | | € 177.00 | € 133.00 |  | Buy Now |
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| Good Documentation & Writing Practices for Regulatory Submissions | 129 | 60 mins | | € 234.00 | € 176.00 |  | Buy Now |
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| Role of RA Specialist in the Design Process | 154 | 40 mins | | € 118.00 | € 89.00 |  | Buy Now |
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| The Australian Regulatory System for In-Vitro Diagnostic (IVD) Devices | 132 | 80 mins | | € 390.00 | € 293.00 |  | Buy Now |
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| The Design, Development and Industrialization of Medical Devices | 183 | 124 mins | | € 366.00 | € 275.00 |  | Buy Now |
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| US FDA 510(k) Notification Process | 92 | 50 mins | | € 152.00 | € 114.00 |  | Buy Now |
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| US FDA Investigational Device Exemption (IDE) Overview | 121 | 125 mins | | € 381.00 | € 286.00 |  | Buy Now |
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| Start-ups & Business Ethics |
| Course Title | ID | Duration | Level | Basic | Premium | PDF | Purchase |
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| Introduction to Medical Devices from Idea to Market: 12 course Suite | 158 | 624 mins | | € 1281.00 | € 961.00 |  | Buy Now |
| Course 1: The Lifecycle of Medical Devices from Idea to Market | 159 | 42 mins | | € 124.00 | € 93.00 |  | Buy Now |
| Course 2: Creating Value in Healthcare | 175 | 44 mins | | € 172.00 | € 129.00 |  | Buy Now |
| Course 3: Business Plan Essentials for Medical Products | 177 | 60 mins | | € 246.00 | € 184.00 |  | Buy Now |
| Course 4: Introduction to the EU Regulatory System | 160 | 36 mins | | € 106.00 | € 80.00 |  | Buy Now |
| Course 5: Introduction to the US FDA | 76 | 25 mins | | FREE | FREE |  | Buy Now |
| Course 6: What is considered a Medical Device? | 161 | 40 mins | | € 118.00 | € 89.00 |  | Buy Now |
| Course 7: Steps to CE Mark | 162 | 52 mins | | € 154.00 | € 115.00 |  | Buy Now |
| Course 8: The Main Concepts for Safe and Performing Devices | 163 | 39 mins | | € 115.00 | € 86.00 |  | Buy Now |
| Course 9: Overview of the Medical Device Design and Development Process | 164 | 77 mins | | € 227.00 | € 171.00 |  | Buy Now |
| Course 10: Product Validation | 165 | 43 mins | | € 127.00 | € 95.00 |  | Buy Now |
| Course 11: Post Market Surveillance | 166 | 34 mins | | € 100.00 | € 75.00 |  | Buy Now |
| Course 12: Intellectual Property Concepts for Medical Devices | N132 | 38 mins | | € 112.00 | € 84.00 |  | Buy Now |
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| Introduction to Digital Governance: A Four-Step Approach | 184 | 57 mins | | € 168.00 | € 126.00 |  | Buy Now |
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| Developing Markets for Medical Technologies: How to Drive Adoption | 220 | 42 mins | MMDP | € 168.00 | € 126.00 |  | Buy Now |
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