Product Lifecycle Management Services
At J Michener Whipple & Partners, we believe it is important to manage product documentation throughout the lifecycle to ensure product risks continue to be identified and mitigated, the product continues to be safe and effective, and the product on the market today matches the market authorization documentation with the global regulatory agencies.
Product documentation created during the Research & Development phase is passed to Manufacturing during Design Transfer and updated throughout the product lifecycle as a part of Post-Market Surveillance and Change Control. R&D documentation is not stagnant, but rather integrated into the lyfecycle of the product.
Source: ISO 14971
By incorporating regulatory compliance and risk management directly into the product in early stages of development, we mitigate early-stage risks and accelerate time-to-market. Integrating ISO 14971 risk management and post-market safety data into iterative cycles for continuous feedback and product improvements ensures long-term market sustainability and patient safety throughout the product lifecycle. Our experts provide hands-on leadership, to help ensure your innovations remain competitive, high-performing, and fully compliant in an ever-evolving market landscape.
Services Include:
Design Transfer & Change Control
Risk Management
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Creation of a Risk Management process for the total product lifecycle
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Recommendation on Risk Management tools
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Creation of lacking Risk Management Files
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Remediation of out-dated Risk Management Files
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Assistance with the linkage of Benefit-Risk-Analysis throughout the product lifecycle, from clinical evaluation through post-market
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Inclusion of mandatory IMDRF codes for Adverse Event Reporting to link Risk Management to Post-Market Activities
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Pragmatic methods for Risk Management Review
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Efficient methods for consistently determining the need for Adverse Event Reporting
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Best practices in design and technical transfer planning and execution, including new products, acquired products, or changes to manufacturing sites
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Creation of best practice Change Control processes, policies and procedures to manage the product lifecycle from pilot production through production ramp up and full commercialization
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Facilities, equipment, process and test method validation
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Creation or update of production process risk management documentation
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Evaluation of Change Control processes
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Cumulative Change analysis for Legacy products
Note: J Michener Whipple & Partners LLC does not provide product Design Engineering services, and will not create product specifications or drawings.
Post-Market Activities
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Incorporation of IMDRF codes into Risk Management and Complaint Management / Adverse Event Reporting processes
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Signal Detection - Identification of appropriate product performance metrics and indicators for post-market corrective actions and/or post-market clinical follow up (PMCF)
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Assessment of Medical Device Reports
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Creation of processes, policies and procedures to link Risk Management, Post-Market Surveillance, Clinical Evaluation and the need for Post-Market Clinical Investigations
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Evaluation of Post-Market Surveillance activities
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Management of field safety corrective actions, product removal or recall
Improvements, Optimization & Cost Savings
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Cost savings through the use of Risk Management tools
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Cost savings through the use of risk-based decision-making and risk-based approach to QMS operations
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Optimization through Lean, Six Sigma and Kaizen events
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Advisory services in Value Engineering
The Collaborative Partner Philosophy
From early-stage design through mature product lifecycle, our consulting services offer the pragmatic expertise required to scale responsibly, integrate quality systems seamlessly, and maintain a competitive edge in complex regulatory landscapes. Partner with us today to create processes that ensure your product’s continued compliance and success throughout its lifecycle.
Ready to Secure Your Product's Success and Discuss Cost Savings?
Schedule an appointment with an expert today