Anna Lundén

Quality systems handbook for medical devices Anna Lundén

New version with references to ISO 9001:2015 and ISO 13485:2016! After thousands of training hours in the Medical Device industry, Anna Lundén has earned a good understanding for what kind of GMP/QSR knowledge that is requested, both for the employees in this industry as well as for people in adjacent companies as suppliers, consultants and contractors. Now Anna Lundén have gathered the most important facts in this book:• Basic knowledge about GMP/QSR in a clear and easy to read style• Comparison of similarities and differences in requirements and terminology in ISO 13485 and US QSR (21 CFR 820)• Tables with specific references to requirements in ISO 13485 and 21 CFR 820• Suitable for self studies and to note references to one’s own activities