Registering a Class 1 Sterile Medical Device - Currently selling a Non-Sterile

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
M Registering a Class II Medical Device with no Predicate Device - FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Requirements for registering Alcohol Wipes (70% IPA) in Canada Medical Device and FDA Regulations and Standards News 4
C Registering Medical Devices in Australia and New Zealand - ANZTPA Other Medical Device Regulations World-Wide 0
K Registering a Software medical device (SaMD) in China China Medical Device Regulations 5
shimonv The regulatory process for registering a Medical Device in India Other Medical Device Regulations World-Wide 2
J ISO13485 Certification Scope - Registering a Subset of our Products ISO 13485:2016 - Medical Device Quality Management Systems 9
M FDA Submission Consultancy - Registering and marketing our products in the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Anvisa & INMETRO - Registering Non-Electrical Medical Devices in Brazil Other Medical Device Regulations World-Wide 2
A Registering Medical Products in Canada - DIN EN 14971 vs. CAN/CSA-ISO 14971 Canada Medical Device Regulations 5
R Registering Medical Device in Brazil ANVISA - Fee Structure Other Medical Device Regulations World-Wide 1
K Job Shop - Registering to AS9100 vs. ISO 9001 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 27
N Regulations for Registering Medical Devices in South Korea Other Medical Device Regulations World-Wide 6
K Registering to AS9100 - Already ISO/TS-16949 Registered AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T Difference between registering as a Lead Auditor with RABQSA vs. IRCA ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 9
M Medical Devices Registering (Registration) Procedure in South Africa Other Medical Device Regulations World-Wide 4
T Product Listing (registering medical devices) in Indonesian Market ISO 13485:2016 - Medical Device Quality Management Systems 2
R Requirements for Registering and Listing with the FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
F Contract Manufacturer Registering with the FDA - Medical Devices - 21 CFR 807.20 ISO 13485:2016 - Medical Device Quality Management Systems 11
A Registering multiple sites to ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
shimonv Clinical evaluation report for class I device EU Medical Device Regulations 1
D Control Number for Class III and IV devices Canada Medical Device Regulations 0
M Class II type machine , and its compliance with 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
J Instructions for use for Class I devices under MDR EU Medical Device Regulations 1
D Electrical Medical Devices class I EU Medical Device Regulations 0
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
L Class IIb devices marked EC according to the 93/42/CE - Portugal CE Marking (Conformité Européene) / CB Scheme 3
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
J Reusable surgical Instrument is under class IIa? EU Medical Device Regulations 4
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
G Voluntary Class I Device Filing Other US Medical Device Regulations 4
J IEC 60601-1-11 Home Class II With Ballasts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
D Can a diagnostic device be class I? EU Medical Device Regulations 1
A AMSQQP416E Class 2 type 2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S IVD risk class II devices for Brazil and MDSAP Other Medical Device Regulations World-Wide 0
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Medical watch Class II (AP Type CF) with USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
L Radiology software Class I exemption Medical Device and FDA Regulations and Standards News 3
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 8
A Class I (exempt) testing requirements Other Medical Device Related Standards 0

Similar threads

Top Bottom