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 […]

MDD (Medical Device Directive) and Medical Device Regulation (MDR) Transitional Provisions

If you have CE marked products in Europe, you may already be aware of the change from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR).  Currently, the MDD is no longer but if you have products that are CE marked under the MDD, Article 120 of the MDR may allow you to […]

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