On Site Training
Once we have helped you to determine your company’s specific training needs, we will work with you to develop an agenda and a timeline to complete the training in the most time-efficient and least disruptive manner to your business. We will bring all of the training materials to your facility. We will also document the training of each employee for your company’s training records.
Regulatory Insight offers training courses that can be provided to every employee within your organization in one session, such as our Quality Systems Overview Course, or we can break the training down to specific job functions, such as Design Controls for your Engineering Team or Process Validation for your Manufacturing Team.
Training can be accomplished all at once or spread out over time. We can offer annual updates or new employee training as well. Our training program is very flexible and can be tailored to fit your exact requirements.
FDA’s 21 CFR §820.25(b): “Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.”
ISO 13485:2016, 6.2: “The organization shall a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to achieve or maintain the necessary competence.”
There is no getting around it – training is a requirement of your Quality System. If your company does not have in-house training personnel, you need to find another way to provide quality systems training to your employees. One option is to send your employees to seminars; however, most seminars only cover certain aspects of the FDA Quality System Regulations and/or ISO 13485 Standard. It can also be very costly to send all of your employees to various seminars; not only considering the actual dollars spent, but also considering the loss of production time for your business while your employees are traveling to these seminars. Lastly, training seminars typically cover very broad and generic topics, which therefore fail to address how to apply the FDA Regulations and/or ISO Standard to your specific business.
When Regulatory Insight assists with your company’s Quality System training, you can customize the type and amount of quality systems training as needed for your employees. We will consider the audience (i.e., your company’s product line and type of operations, along with your employee’s job functions within your organization), and tailor the training to fit only your specific needs. In this way, your employees will be trained specifically on how to apply the requirements of the FDA Quality System Regulations and ISO 13485 Standard as are pertinent to your company, its products and each employee’s specific job function.
Medical Device Submissions
The Principals at Regulatory Insight have over 50 years of combined experience with global regulatory submissions and clinical studies to support those submissions. We know what it takes to get a medical device or IVD cleared, approved, licensed, etc. around the world.
Regulatory Insight maintains an up-to-date industry knowledge base, not only through traditional routes such as industry subscriptions, but through its daily interactions with regulatory body staff around the world. In this way, Regulatory Insight is always current in the most effective ways of getting products through each regulatory body review cycle in the least burdensome, least costly, and least time-consuming manner possible.
Your company may choose to complete its own 510(k), PMA, Canadian Medical Device License Application, Technical File, Design Dossier, etc.; however, you may want to know what options are available (e.g., Traditional versus Modular PMA), or what specific test data are needed for your particular device submission. Regulatory Insight can provide guidance to your company in this regard, including conducting research on applicable regulations and engaging in discussions with the applicable regulatory bodies to determine the specific needs for your device or IVD and the most efficient regulatory path to attaining your goals.
Regulatory Insight can also provide submissions training for your company that covers the basic step-by-step approach to completing a medical device market application. We can focus the training on the requirements for your specific device and explain the different strategies available to you to get your product on the market in the fastest and most cost-effective manner.
Although face-to-face training is arguably the most effective way to train and interact with your employees, especially when it comes to Q&A, perhaps your budget does not allow for the cost of doing on-site training at the moment.
If this is the case, we can arrange to do your training via webinar. Regulatory Insight will make all of the arrangements. Then your employees can either participate as a group from your conference room with a conference phone and the presentation projected onto a large screen, or each employee can simply dial into the conference call and follow along with the presentation slides as they are automatically brought up on their personal computer.
We will control the screen updates so that no one or your end needs to do anything other than sit back and learn.