Training & Consulting
Each tab will direct you to more detailed information about the training and consultancy I provide. To obtain more information or discuss your specific requirements with me at any time, feel free to contact me.
The consultancy I provide is mixed with training such that throughout my work I interface with you and your staff to demonstrate how I complete the task and train them in performing similar tasks.
My work is based on a platform supported by four concepts of Honesty Openness Professionalism and Ethics (HOPE) and each of these have a direct impact on the way I deliver services to my clients:
| Honesty: | Being truthful about the work I do for my clients and any issues that I encounter. |
| Openness: | Transparency in the services I provide and my interactions with my clients |
| Professionalism: | Provide services within the bounds of my competency while performing the work to a high standard. |
| Ethics: | Protect and Treat my clients' interests and information confidentially. |
The most fundamental issue with any medical device is the risk it poses to patients/users and others as well as the environment. From this statement you can see that the most fundamental activity related to any medical device is the management of its risks. The international standard for this type of activity is ISO 14971 which is the accepted standard in most regulatory zones.
Like many other internationally endorsed and accepted standards, the ISO 14971 is not prescriptive and reading the standard for a novice can be confusing or even misleading. There are no standardized textbooks for risk management simply because medical devices are so diverse that the standard has to be adapted for each device or device type. The primary requirement for a successful risk management process is to have an appropriate team with a competent enabler to manage the activity in detail. I have acted in such a role for over twenty years and have covered numerous devices, such as those that are sterile, or combined with drugs, or are liquid or even do not physically exist, i.e. software. I have prepared some guides which can be found in the downloads.
I find helping my clients learn risk management and perform it correctly extremely rewarding and I offer training in this area with details available through the following link: Introduction to Risk Management
Medical devices including In Vitro Diagnostic Devices are highly specialised items and are regulated with complex requirements imposed on those who manufacture, import and distribute them.
The complexity of regulatory requirements for medical devices is a reflection of a the complexity of these devices. A medical device can be an electromechanical product used to help a patient breathe or it can be a tongue depressor the doctor uses to look in a patient’s throat or it can be a plaster or bandage used to dress a wound or it can be a piece of software, an X-Ray film, a CT scanner, a shoe insole, a pregnancy test kit, a glucometer.
The lifecycle of a medical device begins from before its birth as a concept or design and continues for several years after its disposal. Understanding of your legal and professional obligations and knowledge of methods to remain compliant with the law while your device is designed, approved and on the market are not trivial and require many years of experience, comprehensive training and a knowledgeable team to ensure all requirements are met and appropriate evidence is recorded.