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| Proquamed can help ensure your product is developed
using a structured, risk-based approach and is compliant and ready
for the regulatory approval process. The services we provide for each
phase of the product lifecycle are outlined below. Product Definition – Clear and unambiguous user requirements and design inputs are crucial to successful product development. Proquamed can implement or assist in the requirements analysis phase, generating product specifications that meet end user needs, business, regulatory, quality and market requirements. Development – It is critical that a controlled, structured and methodical approach is applied during the development phase to ensure a high quality product is produced. Proquamed help ensure the device design phase is completed in accordance with risk management, quality and regulatory requirements. In addition we have consultants experienced in hardware, electronic and software design and can cost-effectively manage all other aspects of the design process including industrial design, human factors, packaging and labelling. |
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Software – A structured approach to software development is critical for medical devices. Proquamed can help ensure the software in your product is developed using a controlled, risk-based approach that is compliant with regulatory and quality standards and recognised good practice. Design Verification – Verification that design outputs satisfy design inputs is necessary to demonstrate the device has been developed in accordance with cGMP. We can offer design verification services in all areas including the hardware and software components of a medical device. Design Validation – Validation that the medical device meets all user requirements including requirements that encompass any medical device standards, regulatory and specific system requirements must be performed. Proquamed can assist in developing and implementing the appropriate protocols required for validation in the all areas including Clinical Investigation, Software, Hardware, Packaging, Environmental, Sterilisation, and Biocompatibility. Transfer To Manufacture At the end of product development, it is key that transferring a product to manufacture is managed in a controlled manner. We can provide your company with the tools that assist in a smooth transition to product manufacture; we can implement controls, processes and procedures; ensuring all necessary regulatory and quality standards are met. |
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