| Publisher | Kunskapshuset |
| Language | Swedish |
| Book type | Paperback |
| Utgiven | 2016-02-20 |
| Edition | 4 |
| More editions | 2024/0 |
| ISBN | 9789198317466 |
| Kategori(er) |
Under tusentals utbildningstimmar inom industrin har Anna Lundén fått en bra uppfattning om vilka kunskaper som efterfrågas, både för anställda i den Medicintekniska branschen och för personer i angränsande branscher, som leverantörer, entreprenörer och konsulter.
Anna har samlat allt i en bok:
• Grundläggande kunskaper om kvalitetsarbete inom Medicinteknikbranschen på ett lättfattligt och överskådligt sätt
• Jämförelser mellan kraven och terminologin i både ISO 13485 och FDA’s QSR-krav i 21 CFR 820
• Sammanställning av minimikraven på styrande respektive redovisande dokument i dessa båda texter
• Möjlighet till självstudier och att notera referenser till det egna kvalitetssystemet
So far, we have reused
2
4
6
1
1
3
0
books.
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