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The 13485 Store has partnered with |
Please note: classes are purchased directly from BSI and cannot be combined
with purchases of 13485 Store products at this time. | Essentials of ISO 13485 |
Course: Essentials of ISO 13485 (Self-paced) Duration: 1 Hours Description: BSI's Essentials of ISO 13485:2003 eLearning course provides a comprehensive introduction to this standard. Provides a general understanding of the essential concepts of the ISO 13485 standard and how the requirements impact the day-to-day operations of organizations. The course explains the clauses of ISO 13485 in some detail, providing a base for understanding the Quality Management Principles. |
| Overview of ISO 13485 |
Course: Overview of ISO 13485 (Recorded Webinar) Duration: 2 Hours Description: Provides a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485. Students learn how ISO 13485 helps organizations improve their ability to meet customer and regulatory requirements and enhance the quality and safety of their products. In addition, students gain an introduction to the concept of risk management as described in the standard ISO 14971:2001, Application of Risk Management to Medical Devices. |
| Overview of ISO 14971 |
Course: Overview of ISO 14971 (Recorded Webinar) Duration:2 Hours Description: Provides information on the impact that ISO 14971:2007 has on the decision making process of a medical device manufacturer who is registered or soon to be registered to ISO 13485. This webinar offers medical device professionals insight into how ISO 14971:2007 can improve business and risk management efforts. |
| Overview of CE Marking for Medical Devices |
Course: Overview of CE Marking for Medical Devices (Recorded Webinar) Duration: 2 Hours Description: CE marking is a legal requirement for medical devices intended for sale in Europe. This course gives students a broad understanding of the requirements of the Medical Device Directive and the CE Marking approach. Participants learn the basic and initial steps an organization needs to take, to sell their medical devices in the European market by gaining an overview of how the Directives are structured. |
| Overview of CMDRs and CMDCAS |
Course: Overview of CMDRs and CMDCAS (Recorded Webinar) Duration: 2 Hours Description: Provides information on the guidelines of the Canadian Medical Devices Conformity Assessment System (CMDCAS) and on how it will affect business in Canada. An experienced instructor will lead participants through exercises and discussion points. |
| Japan's Regulations for Medical Devices Manufacturers |
Course: Japan's Regulations for Medical Devices Manufacturers (Recorded Webinar) Duration: 2 Hours Description: Provides participants with the vital information they need to place products on the world's second-largest medical device market. This webinar is designed specifically for manufacturers exporting medical devices to Japan and provides an understanding of recent regulatory developments, including the revised Pharmaceutical Affairs Law (PAL) of 2002, which came into force on April 1, 2005. |
| Essentials of Quality Management Systems - Auditing Process |
Course: Essentials of Quality Management Systems - Auditing Process (Self-paced) Duration: 1.5 Hours Description: This course covers the essential skills to conduct a management system audit. The interactive approach utilized reinforces the basic auditor skills of planning, note taking, report writing and audit closure. In, addition, interactive testing at the end of the course will confirm your understanding of the material. The auditing of a process-based system will be emphasized. |
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