Free Training, Coaching & Mentoring
Ideal for Individual Start-Up Companies, Universities and Accelerator Hubs
To help ensure as many medical devices get to market, Richard is committed to educate as widely as possible and donates 20% of his time to training and mentoring entrepreneurs so that they better understand the regulatory landscape they have to operate in. One-to-one and group training sessions can be provided for accelerator hubs, universities and hospitals free of charge. There is never any hard sell, just straight forward education to help those starting out on how to meet the regulatory requirements.
Training is tailored for each situation, but will likely focus on explaining the 3 fundamental principles for regulatory compliance:
- Medical Device Regulations. Understanding the Regulations for Medical Devices; how to navigate them and how to meet their requirements for safety and performance.
- Design Control. How to develop a compliant medical device and the importance of documenting Design Inputs.
- ISO 13485. What is it, why is it necessary and how to meet its strict requirements?
Please contact Richard to learn more.
QMS & TFT Training
In addition to the free training described above, training is a fundamental part of each QMS & TFT installation. Training will be a mixture of on-site and remote training over Zoom. This training usually takes between 2 - 5 days, depending on the level of understanding of Regulations and ISO 13485 that already exists within the clients organisation and the exact package of work purchased.
The Design Workshop is a way to either, kickstart an old project, accelerate a new project or document this part of the product development that may have been missed. All outputs from the workshop are essential parts of a compliant Technical File. The aim of the workshop is to document the Design Inputs, identify the Hazards & initiate a Risk Assessment. All of this is held together and underpinned by a Traceability Matrix which will ensure Design Outputs meet the Design Inputs and provide you with a method to create a Master Validation Plan.
Add a handful of essential SOP’s to the Design Workshop to instruct on design processes compliant with ISO 13485, to aid Design Control and provide traceability for all scientific findings (adds ½ day to training).
Contact us today to see how we might help you!.