A Guide to Training Management for Medical Devices

1. A Guide to Training Management for Medical Devices Elexes.com

2. /02 Introduction Are the employees in your medical device manufacturing company skilled enough to produce qualitative and safe products? Do you have any evidence to ensure their competency? These two questions often trouble manufacturing companies a lot. Medical device training is a regulatory compulsion that the FDA and international governing bodies impose on manufacturing companies in the USA, ensuring the development of reliable products.

3. /03 Laws Regulating the Importance of Medical Device Training Certain laws mandate the requirement of medical device training in the medical device manufacturing industry. According to these laws, it is essential to create procedures to identify employee training needs and ensure training effectiveness. These laws include:

4. /04 FDA Quality System Regulation (QSR) Certain laws mandate the requirement of medical device training in the medical device manufacturing industry. According to these laws, it is essential to create procedures to identify employee training needs and ensure training effectiveness. These laws include: FDA 21 CFR Part 820 outlines the QSR for medical device manufacturing companies. In terms of personnel training requirements, the QSR allows medical device companies to define their methods for meeting requirements. Elexes is the best medical device manufacturing company. However, it also requires: ⦿ Employees are to be trained according to the Standard Operating Procedure (SOP) for their tasks. ⦿ Have proof of specialized training (if required) like welding. ⦿ Employees detecting defects must have specific training for that role. ⦿ Companies to determine general and job-specific training needs. ⦿ Each SOP is to have a training record and each employee is to maintain a personal training log.

5. /04 ISO 13485 The ISO 13485:2016 Clause 6.2 Human Resources also states specific personnel training requirements in medical device manufacturing companies. According to ISO 13485 training, you must ensure personnel affecting product quality are competent based on their education, training, skills, and experience. You must also document the procedures of establishing competence, providing training, and ensuring personnel awareness. Furthermore, you must: ⦿ Determine the necessary competence for quality-related roles. ⦿ Provide training or actions to achieve/maintain competence. ⦿ Evaluate the effectiveness of these actions. ⦿ Ensure personnel understand the importance of their activities and their impact on quality objectives. ⦿ Keep records of education, training, skills, and experience.

6. /06 Thank You www.elexes.com Sheridan, Wyoming 82801, US