Computer Software Assurance for Production and Quality System Software

The FDA recently proposed draft guidance: Computer Software Assurance for Production and Quality System Software.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 […]

Food and Drug Administration (FDA) Transitions from QSR to QMSR

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 […]

ISO 13485: Document Numbers for records, record retention, compliance calendar

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 […]

ISO 13485: Selecting Suppliers and staying compliant

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 […]

ISO 13485: Selecting Suppliers and staying compliant

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 […]

EU MDR PRRC… Let me explain!

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 […]

What are Clinical Evaluations and how they may affect your business?

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 […]

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