Training Institute
Medical Devices - Regulatory Affairs - Quality

Sigma understands the value of knowledge, training and education and how they have the potential to impact lives, businesses and communities. Thus, we have created the Medical Device Training Institute providing basic, intermediate and advanced level training in key areas relevant to the medical device industry. Our mission is to provide continued education and practical knowledge so engineers and administrators stay in compliance with regulations and medical devices are developed, manufactured and distributed in a safe and effective manner.

Audience

The Medical Device Training Institute is directed to those working in the medical device industry. The curriculum provided is unique and not completely found in advanced biomedical engineering or regulatory affairs courses at the college level. A great deal of managers, quality engineers, and product development engineers and scientists are not formally trained in medical device regulations, quality management systems and/or product compliance issues. This can cause product delays, lack of compliance, and resources not effectively used in the product development or manufacturing processes. The training is aimed to provide introductory, high-level or advanced knowledge in key areas to those who are regularly involved in the medical device development, manufacturing or distribution industries. Training certificates are provided and can be used to demonstrate compliance with resource development in ISO13485 (2016), section 6.2: Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.

Training levels

Training is provided at various levels, depending on the knowledge and expertise of the participants in each course. Our instructors have years of practical experience in every subject taught, and are experienced in training and education. Training is provided Online through 1-hour Webinars, 2-4 hour short courses and 6-12 hour courses. Participants are given the opportunity to interact with the instructors and discuss topics relevant to their specific industries. Courses include real and success cases of regulatory affairs, product approval process and quality management systems operations. Training can be used to satisfy ISO13485 requirements in terms of human resource training.

Course Customization

Characteristics

• Online - synchronous and offline
• Live instructor interaction
• Learn at your own pace
• Short training for executives and managers
• Short term courses for employees
• High ROI
• Meets ISO13485 (6.2) Human resource requirements