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By Marcelo Trevino, independent expert | Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the obligations of importers and distributors who engage in relabeling and repackaging activities. | |
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By Matt Burton, IMed Consultancy | One area that medical device manufacturers often overlook in post-market surveillance (PMS) planning for EU MDR and EU IVDR compliance is the role of the supply chain. | |
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By Sandeep Desai, Empower Pharmacy | Hydrogen peroxide (H2O2) is one of the most frequently used chemical compounds for sterilization. This article compares the benefits and trade-offs of using the vapor form vs. aerosol form. | |
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| Cultural Audits: What Are They And Why Are They Essential? | Article | B. Braun OEM Division | The medical device industry is familiar with quality audits, but is less familiar with the benefits of having a cultural audit to assess the competence, dedication, and passion that each party brings to the table. |
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