Search
Close this search box.

A Step-by-Step Guide to Performance Evaluation for IVD Devices by Operon Strategist

Performance evaluation is a crucial step in the development and validation of in vitro diagnostic (IVD) devices. It ensures that...

BD, a global medical technology company, has recently announced its expansion of access to advanced image-enabled, spectral cell sorters. This...

Greenlight Guru Clinical is a leading provider of quality management software for the medical technology industry. Their platform offers a...

Greenlight Guru, a leading provider of quality management software specifically designed for the medical device industry, has once again proven...

Managing budgets and meeting milestones are crucial aspects of conducting successful clinical investigations in the field of medical technology (MedTech)....

The National Medical Products Administration (NMPA) in China has been busy in April 2024, with several important updates and developments...

The Food and Drug Administration (FDA) has recently announced that it will be clearing the use of Bluetooth technology in...

The Food and Drug Administration (FDA) has recently announced that it will be clearing Bluetooth medical devices for use in...

The National Medical Products Administration (NMPA) recently issued a new guideline aimed at improving usability engineering in medical devices. This...

The National Medical Products Administration (NMPA) in China recently issued a new guideline for usability engineering in medical devices. This...

As the global healthcare industry continues to expand, medical device manufacturers are increasingly looking to explore international markets to tap...

As the global healthcare industry continues to expand, medical device manufacturers are increasingly looking to explore international markets for growth...

Sequana Medical, a leading medical device company focused on the development of innovative solutions for the management of fluid overload...

Healthcare cloud computing has revolutionized the way medical devices are managed and operated in the healthcare industry. By utilizing cloud-based...

BioCardia, a leading biotechnology company focused on the development of innovative regenerative therapies for cardiovascular diseases, has recently received a...

ElectroCore, a leading bioelectronic medicine company, has recently been awarded a grant to further develop a groundbreaking treatment for post-traumatic...

The Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and efficacy of medical products in...

Drug-device combination products are becoming increasingly popular in the healthcare industry, offering a unique approach to treating various medical conditions....

Haryana, one of India’s leading states in terms of industrial development, has recently announced its ambitious Medical Device Manufacturing Policy...

Colorectal cancer is a type of cancer that starts in the colon or rectum, and it is the third most...

Drug-device combination products have become increasingly popular in the healthcare industry, offering a unique approach to treating various medical conditions....

Vapotherm, a leading global medical technology company, is set to introduce its latest innovation, the Access365 Home Ventilation Solution, at...

Medtronic, a global leader in medical technology, recently announced a strategic shift in its approach to ventilators in response to...

Health Canada plays a crucial role in ensuring the safety and effectiveness of medical devices in Canada. One important aspect...

Health Canada plays a crucial role in ensuring the safety and effectiveness of medical devices in Canada. One important aspect...

Sysmex Corporation, a leading global healthcare company, has been making waves in the field of robotics with its innovative approach...

The INHALE-3 study, a groundbreaking clinical trial comparing the efficacy of Afrezza® with traditional insulin delivery methods, has recently released...

Starting April 1, RF Aesthetic Equipment will need a Device Certificate As of April 1, 2022, all Radio Frequency (RF)...

Genesis MedTech, a leading medical technology company, has recently announced a partnership with Silk Road Medical to improve healthcare access...

Genesis MedTech, a leading medical technology company, has recently announced a partnership with Silk Road Medical to improve healthcare access...

Managing Training and Ensuring Compliance with ISO 13485:2016 and Part 820.25: A Guide

Introduction

ISO 13485:2016 and Part 820.25 are two important standards that govern the quality management systems of medical device manufacturers. These standards outline the requirements for ensuring the safety and effectiveness of medical devices, as well as the processes that must be followed to achieve compliance. One key aspect of compliance with these standards is ensuring that employees are properly trained on the requirements and procedures outlined in ISO 13485:2016 and Part 820.25.

Importance of Training

Training is a critical component of compliance with ISO 13485:2016 and Part 820.25. Proper training ensures that employees understand the requirements of the standards and are able to effectively implement them in their day-to-day work. It also helps to ensure that employees are aware of their responsibilities and can identify and address any non-conformities that may arise.

Training also plays a key role in maintaining a culture of quality within an organization. By providing employees with the knowledge and skills they need to perform their jobs effectively, training helps to ensure that products are manufactured in accordance with the standards and that customer expectations are met.

Managing Training

To effectively manage training and ensure compliance with ISO 13485:2016 and Part 820.25, organizations should follow a structured approach. This includes:

1. Identifying Training Needs: The first step in managing training is to identify the specific training needs of employees. This may include training on the requirements of ISO 13485:2016 and Part 820.25, as well as training on specific processes or procedures within the organization.

2. Developing Training Programs: Once training needs have been identified, organizations should develop training programs that address these needs. Training programs should be tailored to the specific requirements of ISO 13485:2016 and Part 820.25, as well as the needs of individual employees.

3. Delivering Training: Training programs should be delivered in a way that is accessible and effective for employees. This may include classroom training, online training, on-the-job training, or a combination of these methods.

4. Monitoring Training Effectiveness: Organizations should monitor the effectiveness of their training programs to ensure that employees are gaining the knowledge and skills they need to comply with ISO 13485:2016 and Part 820.25. This may include conducting assessments, surveys, or evaluations to measure the impact of training on employee performance.

Ensuring Compliance

In addition to managing training, organizations must also take steps to ensure compliance with ISO 13485:2016 and Part 820.25. This includes:

1. Documenting Training: Organizations should maintain records of all training activities, including the content of training programs, attendance records, and assessments of employee performance.

2. Conducting Audits: Regular audits should be conducted to assess compliance with ISO 13485:2016 and Part 820.25. Audits may include reviewing training records, observing employee performance, and identifying areas for improvement.

3. Corrective Actions: If non-conformities are identified during audits, organizations should take corrective actions to address these issues and prevent them from recurring in the future.

Conclusion

Managing training and ensuring compliance with ISO 13485:2016 and Part 820.25 is essential for medical device manufacturers to maintain the safety and effectiveness of their products. By following a structured approach to training and compliance, organizations can ensure that employees have the knowledge and skills they need to meet the requirements of these standards and deliver high-quality products to customers.