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The FDA recently proposed draft guidance: Computer Software Assurance for Production and Quality System Software. The guidance provides recommendations regarding computer software assurance for computers or automated data processing systems used as part of production or the quality system. Per 21 CFR 820.70(i) Automated processes. When computers or automated data processing systems are used as […]

The Food and Drug Administration (FDA) recently presented a webcast to the industry regarding the proposed FDA Quality Management Systems Requirements (QMSR). The FDA QMSR is intended to replace the current US FDA Quality Systems Requirements (QSR – 21 CFR 820) with the Internationally recognized standard ISO 13485:2016: Medical devices – Quality management systems – Requirements for […]

A clever tool for assigning record numbers is to incorporate a year or date into the control number. For example, 2022-097 could represent the 97th record for 2022. This built-in semi-intelligent system is simple and efficient, especially in companies that have been in business for several years. Having the year embedded in the number is […]

Perhaps you have already trained everyone on a new standard or requirement. But how do you periodically reinforce the knowledge?  One idea is to create a deck of requirement flashcards. Each card lists a regulatory requirement on one side and then a fun fact or information on the other. Put them in the lunchroom or […]

One of the most essential aspects of conformance is documentation and it is essential to how the documentation is structured. What is the outline structure of your documentation? For most organizations, it is best described as a pyramid where the quality manual is the top tier (apex) with procedures and then working documents below. Records […]

Nothing is simple in the beginning for a supplier and selecting a supplier is one of them. The organization must establish criteria for the evaluation and selection of suppliers. For a start-up company with an innovative product, this can be problematic as choices for suppliers may be limited.  Parts may only be available from a […]

Nothing is simple in the beginning for a supplier and selecting a supplier is one of them. The organization must establish criteria for the evaluation and selection of suppliers. For a start-up company with an innovative product, this can be problematic as choices for suppliers may be limited.  Parts may only be available from a […]

A high number of complaints is not necessarily indicative of poor device quality. There could be many reasons for large number of complaints. Customers may be dissatisfied when they have expectations beyond the capability of what a device can do. There could be a requirements mismatch. A manufacturer may have return policies that inadvertently encourage […]

The EU Medical Device Regulation (MDR) requires manufacturers to have available at least one person, within their organization, responsible for Regulatory Compliance. That person is known as Person Responsible for Regulatory Compliance or PRRC (we love acronyms!). For a Micro and/or small enterprise, the PPRC does not need to be within the manufacturer’s organization but must […]

A Clinical Evaluation is an assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer. A Clinical Evaluation is required for all medical devices to be marketed in Europe. Alternative treatment options including no treatment should be […]