Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020)

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
Ed Panek Website to ask FDA for guidance in Medical Device Industry? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C Medical Device Website Change Control ISO 13485:2016 - Medical Device Quality Management Systems 3
Ronen E FDA's enforcement over Website Claims (Medical Device Misbranding) Other US Medical Device Regulations 7
C How to find the Medical Device Listing Number (MDL Number) from the FDA website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
L Is there an Official Website for Medical Device Registration Information EU Medical Device Regulations 12
M Medical Device Website Document Control - Clinical Advice or Performance Claims Document Control Systems, Procedures, Forms and Templates 2
V Website Document Control - Medical Device Product Document Control Systems, Procedures, Forms and Templates 10
B Telemedicine as a Medical Device EU Medical Device Regulations 4
S Definition of disease as per medical device defintion EU Medical Device Regulations 14
Q Class I Medical Device with measuring function (UK MDR 2002 / MDD) UK Medical Device Regulations 3
G No new regulations in Austria medical device register after 26th Mai, 2022 EU Medical Device Regulations 0
A What activities are included in the action of marketing you medical device in U.S.? Medical Device and FDA Regulations and Standards News 1
M CE marked medical device - do they need UKAS certified calibration provider ISO 17025 related Discussions 4
C Is there a list of products or classifications subject to medical device regulations in El Salvador? Other Medical Device Regulations World-Wide 0
R Class II Active Medical Device SYSTEMS and COMPONENTS Canada Medical Device Regulations 2
B Rework of a medical device EU regulations EU Medical Device Regulations 5
S Drawing Requirements for Catalog Items (Class II Medical Device) US Food and Drug Administration (FDA) 3
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
C Regulatory Affairs in a start-up medical device company Career and Occupation Discussions 1
somashekar Medical device file Vs Role undertaken by the organization ISO 13485:2016 - Medical Device Quality Management Systems 1
M Medical Device Label - Language EU Medical Device Regulations 2
D MDR: Active medical device or not? Medical Information Technology, Medical Software and Health Informatics 14
H Mapping QMS+business processes in a medical device with class I and IIa+b Process Maps, Process Mapping and Turtle Diagrams 3
Aliken Registration veterinary medical device (laser) requirements Medical Device and FDA Regulations and Standards News 2
T Classification Accessory Software medical device EU Medical Device Regulations 4
J CGMP Medical device slide deck Manufacturing and Related Processes 1
M Notification Requirements for Medical Device Raw Materials 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Madagascar medical device regulation Other Medical Device Regulations World-Wide 0
R Steam sterilizer medical device reclassification EU Medical Device Regulations 6
G Software Medical Device Classification EU Medical Device Regulations 7
J Robotic arm with a camera, active medical device? EU Medical Device Regulations 12
D Out of specification procedure for Medical device manufacturing Manufacturing and Related Processes 7
K Medical Device Shipping Container Label Manufacturing and Related Processes 3
S Is Amalgam Separator considered a Medical Device in US and EU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K New to Medical Device QMS and would like advice ISO 13485:2016 - Medical Device Quality Management Systems 9
C Medical device label storage conditions EU Medical Device Regulations 11
W Regulation of medical device in Hong Kong Other Medical Device Regulations World-Wide 2
M Inspiring leaders in the medical device industry ISO 13485:2016 - Medical Device Quality Management Systems 5
A Layered Process Audits for Medical Device Manufacturing? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Transferring medical data from a device (Sec 201(h)): regulatory implications US Medical Device Regulations 3
R Is "SAFE" permitted in class 1 medical device marketing claims? US Medical Device Regulations 1
T Determining FIPS 140-2 compliance in a medical device Medical Information Technology, Medical Software and Health Informatics 2
I Importing medical device into Canada for exclusive distribution in the U.S. Medical Device and FDA Regulations and Standards News 0
M Camera / microphone with wifi connection on a medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A QMS inside a Non medical device firm ISO 13485:2016 - Medical Device Quality Management Systems 4
J Medical Device Component Change - Testing, Sampling Criteria ISO 14971 - Medical Device Risk Management 3
A Labeling Requirements for Medical Device Travel Case US Medical Device Regulations 9
Judy Abbott Guideline as for devices utilizing plants and their derivatives in medical device US Food and Drug Administration (FDA) 6
B Registration of a CE-marked medical device in Japan -Will they accept conformity with GSPRs? Japan Medical Device Regulations 0

Similar threads

Top Bottom