SBS - The Best Value in QMS software

EU - New Medical Devices Regulations agreed upon!

Elsmar Forum Sponsor

Yasuaki

Starting to get Involved
#3
:(So, we must gain four new certificates in a couple of years, if necessary.
ISO 9001:2015 Certificate by 2018
ISO 13485:2016 Certificate by 2019
MDSAP Certificate by 2019
MDR Certificate by 2019 or 2020

Many people engaging audit and/or certificate may be going to get heavily tired.
 

Ajit Basrur

Staff member
Admin
#5
:(So, we must gain four new certificates in a couple of years, if necessary.
ISO 9001:2015 Certificate by 2018
ISO 13485:2016 Certificate by 2019
MDSAP Certificate by 2019
MDR Certificate by 2019 or 2020

Many people engaging audit and/or certificate may be going to get heavily tired.
Very true :)
 
Thread starter Similar threads Forum Replies Date
L EOL milestone in Medical Devices Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 0
dgrainger Informational DRAFT: The Medical Devices (Northern Ireland Protocol) Regulations 2021 UK Medical Device Regulations 0
J In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply? UK Medical Device Regulations 6
M Brexit The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 UK Medical Device Regulations 1
M Advertising medical devices in the U.S - Advertising regulations or guidance documents Other US Medical Device Regulations 3
M Informational EU – EMA revised guidance – Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 201 Medical Device and FDA Regulations and Standards News 2
M Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices Medical Device and FDA Regulations and Standards News 13
S China 2018 draft Amendments to the Regulations on the Supervision and Administration of Medical Devices China Medical Device Regulations 1
J Regulations GSM trackers on medical devices EU Medical Device Regulations 2
S What does SOR and DORS stand for in the Medical Devices Regulations? Canada Medical Device Regulations 2
W Wireless RF Regulations and Standards for Medical Devices sold in the EU EU Medical Device Regulations 2
G Further steps in Medical Devices Regulations in EU - Comments? EU Medical Device Regulations 11
L Australia/Canada and USA v's EU Medical Devices Regulations Comparison Other Medical Device Regulations World-Wide 4
A Japan Medical Devices Vigilance Regulations or Guidelines Japan Medical Device Regulations 4
M Global Radio Frequency Regulations for Medical Devices Medical Information Technology, Medical Software and Health Informatics 3
S EU Medical Devices (Amendment) Regulations 2012 have been published EU Medical Device Regulations 2
P Regulations to Register Medical Devices in Republics of former Yugoslavia Other Medical Device Regulations World-Wide 2
N China's Regulations regarding Labels on Class II Medical Devices China Medical Device Regulations 4
D Chinese Regulations for the Supervision and Administration of Medical Devices China Medical Device Regulations 2
N Regulations for Registering Medical Devices in South Korea Other Medical Device Regulations World-Wide 6
M Medical Devices Compliance and Regulations Overview 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A CE Marking Standards and Regulations for Medical Devices - Guidance needed EU Medical Device Regulations 7
P Regulations concerning Calibration of Stop Watches used for Testing Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
W Do FCC regulations apply for Medical Devices other than EMC? US Food and Drug Administration (FDA) 3
T Medical Devices Regulations Association Membership Other Medical Device and Orthopedic Related Topics 2
chris1price Export of Medical Devices to Iran - Medical Device Regulations in Iran ISO 13485:2016 - Medical Device Quality Management Systems 25
T Japan Medical Devices Regulations Japan Medical Device Regulations 9
I FDA regulations for medical devices distributor in US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Iran - Medical Devices Regulations - Homologation ISO 13485:2016 - Medical Device Quality Management Systems 2
Ajit Basrur Are there any New Regulations for Medical Devices? ISO 13485:2016 - Medical Device Quality Management Systems 8
S IFU Font Size - Specified by any regulations for medical devices on sale in the US? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
R Syria regulations - Registration and sale of medical devices to Syria ISO 13485:2016 - Medical Device Quality Management Systems 6
H Japanese Regulations for Medical Devices - Three Questions ISO 13485:2016 - Medical Device Quality Management Systems 6
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Stability sampling for Class 1 medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
D Clinical Trial for Medical devices in Canada Canada Medical Device Regulations 1
M California Board of Pharmacy License for Medical Devices?? Other US Medical Device Regulations 6
P Retention Samples for medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
dgrainger Informational EC - Medical devices – online manuals replacing paper instructions - Feedback period: 27 April 2021 - 25 May 2021 EU Medical Device Regulations 0
R "Medical devices" required in scope ISO 13485:2016 - Medical Device Quality Management Systems 2
R X-RAY Based Diagnostic Veterinary medical Devices Medical Device and FDA Regulations and Standards News 2
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
A Brexit Mandate for EU Authorised Representative for non medical devices CE Marking (Conformité Européene) / CB Scheme 7
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 2
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 2
B Procedure packs with non-medical devices EU Medical Device Regulations 1
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4

Similar threads

Top Bottom