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Planning Right

Hazard Analysis/Risk Assessment and Risk Management

Analyzing potential hazards, assessing potential risks and implementing mitigation are the backbone of medical device development and quality compliance.

ISO 14971 has become the international currency of risk analysis and mitigation. FDA expects a medical device manufacturer to integrate risk management effectively throughout the lifecycle of the product.

The risk management culture of a company shows through in all aspects of product and marketing management, but it starts at the development phase. Some regulatory submissions require inclusion of the risk analysis in the documentation.

Paladin Medical® can guide your team through the early work of design level risk analysis and qualification planning. Integration of risk analysis into a solid Design Control and Review program is necessary for efficient and effective risk controls.

Process level hazard analysis and risk mitigation is a valuable tool to determine which elements of medical device manufacturing and production may introduce risks to the user, the patient, or the quality of the device.

Software and hardware risk analysis can help to isolate within the integrated requirements where risk mitigation is necessary. With complicated systems it is often necessary to ensure the user can effectively perform their required role. SEE HUMAN FACTORS and USABILITY STUDIES.

Continual product performance monitoring through complaint monitoring and analysis systems, medical device adverse effect monitoring, and change control management are at the core of reducing risks in order to assure patient benefit. Paladin Medical provides expert services that train and enable your personnel to integrate these principles into product quality programs.
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Software Wisdom

If your product incorporates software, or IS software, your team must be fully aware of all FDA guidance documents and international standards affecting your software qualification. Although FDA issued a “final” guidance in 2023 concerning “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff”, this is far from the only guidance you need. There are no less than FIVE major software guidance documents to consider, contingent upon the intended use of your device and the source of software. Also, you may not even realize that your “app” could be seen by FDA as a medical device! You might want or need specialized software contract vendors to either design or test your software. Don’t try this alone! We suggest you contact Paladin Medical® during your feasibility phase so we can help you take inventory on the requirements your software will need to meet and from whom you may want services.
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Human Factors and Usability Studies

USER ERRORS can undermine the performance of a medical device and introduce risks. Qualification of some new medical devices (and changes) can require assessment of the user’s ability to properly employ the device as intended. It is not uncommon for a design level risk analysis to reveal intrinsic hazards associated with the use of the device, such as radiation hazards, which can be mitigated by design. But it is also true that the environment of use can contribute to risks or the interface between the device and user. Design consideration for factors related to human use (and the experience of the user) may affect the safety and performance of the device. Aspects such as design of displays and controls, interfaces with other electronic units and even the user instructions contribute to safety and performance. Our experience with these aspects of human factor design, assessment and evaluation can contribute to the work your team may undertake to assure device safety and performance in its intended use environment.
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Device Master File (MAF)

Companies that sell materials, components or manufacturing services should consider the benefits of a DEVICE MASTER FILE (MAF) with the Center for Devices and Radiological Health (CDRH) and you may wish to inquire if a materials supplier has a MAF with FDA. A Master File is a separate filing to FDA (no fee for filing) which holds proprietary processing and qualification information held by the material or process producer which remains “outside” of the premarket submission. Originally conceived as a means for submitting data in support of a PreMarket Approval Application (PMAA), Master Files now serve to support Investigational Device Applications, 510(k) applications and deNovo submissions. The Device Master File owner controls the content and access by FDA to the file by way of a letter to the customer. The access letter is provided by the customer to FDA as part of their submission.

Paladin Medical® can help you get started and can work with you to create this valuable asset from your existing documentation. It is important to craft the access letter so that the FDA has access to the specific information necessary to support the premarket submission at hand, and not a blanket access. The value of this access by FDA to the proprietary information about your material, quality systems and prior testing can greatly speed the approval of the candidate device and reduce the additional testing by the customer. We can also support the continual updating of the Master File and support the communication between the holder of the Master File and the customer.
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