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Design Control

ISO is a voluntary standard that contains section 7. The objective of Design Controls, in this context, is to require that manufacturers follow a methodologically-sound process to develop a medical device, with the intent of improving the probability that the device will reach an acceptable level of efficacy and safety.

Examples of design input [1] :.


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From Wikipedia, the free encyclopedia. Retrieved June 15, Outline Portal Designer. Automotive design Automotive suspension design CMF design Corrugated box design Electric guitar design Furniture design Sustainable Hardware interface design Motorcycle design Packaging and labeling Photographic lens design Product design Production design Sensory design Service design.

Design Controls - Requirements for Medical Device Developers

Algorithm design Behavioural design Boiler design Database design Drug design Electrical system design Experimental design Filter design Geometric design Job design Integrated circuit design Circuit design Physical design Power network design Mechanism design Nuclear weapon design Nucleic acid design Organization design Process design Processor design Protein design Research design Social design Software design Spacecraft design Strategic design Systems design. Design Inputs are a set of technical specifications with quantifiable design boundaries that represent a translation of the customer requirements into measurable engineering terms.

As a design evolves and test methods and acceptance criteria are better determined, the Design Inputs document is supposed to be updated and treated as a formal revision-controlled document.

Frequently, Design Inputs are incomplete, unclear, or not measurable. Without adequate Design Inputs, the risk of completing qualification all the way through clinical studies only to find problems during expensive clinical studies is increased. During the early stages of development, risk analysis that identifies and evaluates the risk associated with various potential product failure modes should be conducted. For complex product systems, Fault Tree Analysis can be an effective alternative for risk analysis. Risk analyses are done prior to final qualification testing since verification and validation testing frequently are part of risk mitigation.


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Design For Six Sigma DFSS is frequently applied to critical design elements to ensure a statistically adequate safety margin in reliably meeting requirements. Early identification of potential risks allows the project team an opportunity to adjust the design or process, or to mitigate the likelihood of occurrence or potential severity of the hazard.

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This reduces the possibility of a last-minute major program setback. Unfortunately, risk analyses are not always comprehensive and risks are not always fully mitigated. This can ultimately lead to recalls of commercialized products, or expensive product re-engineering programs. Even with the most rigorous of efforts to develop risk analysis, there are legitimate unknowns regarding frequency of occurrence of certain failures when estimated early during product development.

Top 5 issues for developing medical device design controls within the context of risk management

This is why risk analysis documents must be updated periodically as frequency of occurrence or severity of the hazard become better understood or new failure modes are discovered. Risk Management is central to implementation of and compliance with Design Controls. Expectations and best practices in the utilization of Risk Management have evolved significantly over the past 10 years.