Process Development
Process development in the realm of medical devices is a meticulously regulated endeavor, necessitating strict adherence to applicable standards. This rigorous process begins with a comprehensive analysis of user needs and device specifications, followed by design controls and risk assessments. Validation, a crucial phase, involves thorough testing to confirm consistent adherence to specified criteria, aligning with Good Manufacturing Practices (GMP). Throughout, meticulous documentation, including Design History Files (DHF) and Device Master Records (DMR), is pivotal for traceability and regulatory compliance. This commitment to precision is not only a regulatory mandate but also an ethical imperative, safeguarding the safety and well-being of patients who rely on these medical devices. PMforMedTech helps your organization to design, develop and validate your process.
Establishing a New Production Line
From selection of raw materials, suppliers to deciding on the make/buy strategy, to selection of required human resources and to make sure the process is validated properly, the entire Production Line establishment activity is a cumbersome process that entails lots risks. Over the years of experience we have built in the industry we have lots of "lessons learned" items that we are happy to share with you and your organisation.
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Process Validation
Process validation typically consists of three stages: process design, process qualification, and continued process verification. The process design phase defines the manufacturing process, identifying critical parameters and controls. During process qualification, comprehensive testing(UAT, FAT, SAT, IQ, OQ, PQ, PPQ) and documentation are performed to ensure the process consistently produces devices meeting specifications. Finally, continued process verification involves ongoing monitoring and assessment to guarantee the process's stability and performance over time.
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Computer Systems Validation (CSV)
As often referred to as software validation, CSV is defined by FDA as "Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled". It is basically developed to control that the system does what it promises to do at every level (V Model according to GAMP Guides).
Verification confirms and reviews tasks within the validation process. It includes review and approval of specifications (URS, FS, Designs), formal design reviews, code walkthroughs, testing (IQ, OQ, PQ), trace matrices (confirming all URS addressed in FS and Design, confirming all specifications tested), validation report (confirming all validation activities complete, acceptance criteria met). Verification could also include confirmation of training materials, user and tech SOPs, DRPs, etc.
Qualification is the formal testing of requirements in either the URS, FS or Design document. You perform these tests during the IQ, OQ and PQ stages of the validation process.
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Site Transfer / Technology Transfer
Site transfer and technology transfer within the medical device industry involve complex processes that carry potential risks and challenges like leading disruptions in production, quality issues or regulatory compliance concerns, potentially compromising patient safety and a company’s reputation. Ensuring a seamless transition necessitates detailed planning by a through consideration of various aspects (supplier, site, utilities, human resources, new validation needs, new SOP requirements and others).