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Our Good Practice Guides are designed to equip your business with all the necessary ingredients to implement current and best practices. You can purchase our eBooks on Good Documentation Practices (GDP), Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP) and much more.
Our knowledge-based products provide instant access to all the latest must-know industry regulations and best practices you require for your business. Our templates will provide your business with a ready-to-use platform for validation. All templates are written in a clear and easy-to-understand format with plenty of pointers and examples.
Stay at the leading edge of industry best practice with our comprehensive range of eBooks. Download hands-on guides and toolkits. Buy expert handbooks and templates to master validation, GxP and GMP.
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GxP is a general umbrella term for good practice guidelines. These guidelines are used in many fields including the medical device, pharmaceutical and life sciences industries. This knowledge pack provides you with a comprehensive overview of all key areas under the GxP umbrella. It will add to your understanding and refresh existing knowledge. GxP Guru is ideal for engineering and science graduates or postgraduate candidates striving to build practical knowledge of GxP.
Design Control for Medical Devices — An Introduction
This eBook introduces the subject of design control in a concise and easy-to-read format, perfect for those new to the subject. Medical devices come in all shapes and sizes with different levels of complexity and risk. They range from simple devices such as bandages, plasters and urine test strips to automated diagnostic devices, orthopaedic implants, bone screws and artificial organs. Manufacturing companies vary in size and structure and in the approach they take to design, development and management practices. All of these elements influence how design controls are implemented and how effective they are. However, a solid understanding of the user needs, patient needs and design control leads to better project outcomes helping to foster better communication and awareness.Design controls are a collection of practices and procedures that are incorporated into the design and development process for a product such as a medical device. It provides a structure and clear path from a user needs assessment through to product delivery by implementing a step-by-step process. Design controls ensure proper assessment of the design is completed during the design and development stage.
Design control highlights technical issues, input requirements and conflicts or deficiencies in design, allowing them to be addressed early on in the process. Fixing a design issue early on reduces the cost of doing so at a later stage and ensures the resultant design is appropriate for its intended use. Design control brings a formal review process to the table which assists engineers and managers in engaging with decisions and understanding them better. It also ensures future changes are made, documented and reviewed adequately with proper consideration given to the design inputs. Design controls are also a requirement of quality systems such as 21 CFR Part 820 (Medical Devices) for certain classes of devices and per and ISO 13485.
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