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Differences ISO 13485:2012 and ISO 13485:2016  
ISO 13485:2016: What are the differences? ISO 13485:2016 introduces changes in comparison to the previous versions of the standard. Thereby ISO 13485 became even closer to the requirements under 21  
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MDSAP  
MDSAP: Medical Device Single Audit Program The Medical Device Single Audit Program (MDSAP) was initiated to satisfy a wish of many medical device manufacturers: To replace the various audits and in  
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EU General Data Protection Regulation GDPR  
EU General Data Protection Regulation GDPR The EU General Data Protection Regulation must be complied with starting at 25 May 2018, at the latest. Many companies, amongst them also medical dev  
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21 CFR Part 11: Requirements You Should Know  
21 CFR Part 11: You should know these requirements In 21 CFR Part 11, the FDA establishes its requirements for electronic records and signatures, which also apply to medical device manufacturers. A  
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Process Validation: Definition & Examples  
Process Validation: Definition & Examples ~ What to Look Out For Process validation is the verification that a process meets the requirements imposed on its process results. Learn when you must  
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Quality Policy and Quality Objectives  
Quality Objectives and Quality Policy For many companies, quality objectives and quality policy fall into oblivion; the focus rather lies on the QM-Systems's conformity with ISO 9001 and ISO 13485,  
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Digitalization of the production  
Digitalization of the production The digitalization of the production is an essential part of the digital transformation of manufacturing companies. However, not all companies benefit to the same  
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Design input: What you shouldn’t forget  
Design input: What you shouldn’t forget “Design Input" refers to the development specifications, and it's not just the FDA that makes concrete demands in this regard. This article describes wh  
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Declaration of Conformity  
EU Declaration of Conformity The EU declaration of conformity is an important legal document in which the manufacturer declares the conformity of their medical device. In this article you will lear  
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Systems and Procedure Packs  
Systems and procedure packs The European legislation defines systems and procedure packs and distinguishes between different configurations. The regulatory requirements placed on the manufacturer a  
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