#Scope means defining the boundaries and applicability of the activities your organisation carries out against #ISO13485 | study Custom #MedicalDevices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

A well-defined scope can help structure ideas from a medical team and focus you on creating safe solutions with specific design characteristics required for individual patients | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

Goal setting is universal. We set goals for our careers, well-being & general life. We'll explore how to write clear and focused goals and ways of tracking if we're getting better or worse | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

Quality objectives are significant goals or targets; they're action orientated, inspiring & help us achieve continual improvement in our QMS & organisation | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

Custom medical devices are life-changing. Managing resources can help make these services more cost-effective and safer, leading to a greater number of benefits for more people | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

Resources are the most significant investments for organisations, encompassing finances, staff, equipment, physical space, technology and time | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

Systematically evaluating & controlling risks forms the backbone of risk management activities, which helps to safely bring the benefits of custom medical devices to a greater number of people | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

Resource management allows your organisation to react effectively to the needs of patients & medical teams. Whether you're part of a large or small team, organisational resources are precious | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

Preparing for the unexpected & preventing harm before it occurs, is a central theme in risk management. Let’s discover how to identify, evaluate & reduce the impact of these risks | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

Failure Modes, Effects & Critical Analysis, or FMECA, is a risk assessment tool to help detect & manage risks associated with your medical device or process, we use a process FMECA | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

Systematically evaluating #risks forms the backbone of risk management activities, which helps to safely bring the benefits of custom #medicaldevices to a greater number of people | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

The safety & performance of medical devices is of utmost importance, let's look at how technical files and clinical evaluation reports produce a body of evidence to facilitate regulatory review | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design PDR Cardiff School of Sport & Health Sciences

To create technical files for #medicaldevices, separate them by their intended #purpose, like #orbitalfloors and #cranioplasty plates; you'll need a technical file for each device subcategory | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

Technical file creation, clinical evaluations & risk management are closely interwoven; containing all evidence to prove your medical devices are safe for use | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

Our patient's safety relies on the quality & reliability of #medicaldevices. The medical device design & manufacturing sector is one of the most heavily regulated around the globe | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

Developing a #qualitymanagementsystem requires a significant & sustained amount of resources. It's a vital way to ensure patient safety, reliability, & demonstrate compliance with regulations | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

#ISO13485 has 8 clauses detailing the requirements of organizations engaged in the design, manufacture and supply of medical devices | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

When our unique appearances change through disease or injury, we can design #reconstructive #implants customised for each patient. We call this 'custom medical device design' | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

Custom medical devices are regulatory riddled & expensive, but the reduced likelihood of revision surgeries & reduced duration of in-patient admissions, the overall treatment cost can decrease | study Custom Medical Devices with Cardiff Metropolitan University PDR Surgical Design | PDR Cardiff School of Sport & Health Sciences

Using #CT scan data for 3D computer-aided planning, #design, and direct #manufacture of the final custom devices is state-of-the-art | study Custom Medical Devices with Cardiff Metropolitan University @pdr_spd | PDR Cardiff School of Sport & Health Sciences