Are you wondering about what a medical device regulatory training can do to help you get your medical devices to the marketplace? Then, this article is for you.
Vicki Partridge has been providing comprehensive medical device compliance training in USA, Asia, Europe, and Australia. She has been helping medical device manufacturers in ensuring their products meet the international regulatory requirements for training. When you attend one of her training and workshops, there are some things you know and do, and that’s what we are going to talk about here.
Know Which Medical Device Training You Need
Before you can place your medical devices in the marketplace, there are specific standard operating procedures (SOPs) and work instructions that you and your employees need to be trained, especially when you are new to the industry.
Vicki Partridge offers a wide range of medical device compliance training courses and compliance certification programs workshops, including:
Medical Device Classification;
Declarations of Conformity;
Procedure Packs and Systems; and
The Role of a Sponsor.
Determine Your Competence
Another issue that many manufacturers deal with is competence. Some of them employ purchasing managers who are high school graduates but have extensive experience in real-world purchasing. However, is that adequate enough for the role? The regulatory authority does not define competency in a linear way. You are, in essence, defining the requirements for the role.
By understanding what your company lacks, you will be able to determine the type of medical device compliance training in the USA, Asia, Europe, or Australia you need.
Document the Training that You Receive
Regulatory bodies often cite manufacturers for failing to document training. For instance, you fail to train production employees who are responsible for quality functions or provide records that demonstrate your employees are performing design control activities. In cases like these, regulatory bodies might call out your attention.
To avoid any complications with your TGA approval process, you should not forget to document or record the medical device compliance training in USA, Asia, Europe, or Australia that you receive.
To make sure that you document the training, you can ask your employees to sign the SOP after having been trained on it. You can also use a training matrix to easily identify job-specific training requirements, track completed training and workshops for individuals and departments, and demonstrate to a regulatory body that training is taking place and being tracked.
More importantly, you should take note that employees performing roles within the realm of the Quality System Regulations for medical devices should undergo training and that documentation of that training is a requirement.
Monitor the Effectiveness of Your Training Efforts
By designing a training matrix, you will be able to keep track of overall training programs. You will also have proof that individual employees have been trained. However, records cannot prove that certain training has been effective. In that case, you will have to assess the effectiveness of training through the following:
Ask your employees if they have learned the information.
Assess their understanding after the training and periodically thereafter.
Evaluate their performance. Make sure they are following SOPs and work instructions.
Work with Vicki Partridge to Bring Your Regulatory Training to the Next Level
Vicki Partridge has been training medical device professionals for many years. She has trained and worked with some of the leading medical device companies in the country in elevating the skills and competence of their employees. When you work with her, she will teach a pilot course, and you will then receive the specific training that you need.
For the most comprehensive medical device compliance training in USA, Asia, Europe, and Australia, choose to work with Vicki Partridge. Get in touch with us to discuss your needs.