Regulatory and More

Talking and sharing topics about regulatory affairs in medtech

[Regulatory and More @AndRegulatory]

How to Create a Project Timeline in Simple Steps?
https://t.co/mreorBKSVp

#medicaldevices #invitrodiagnostics #regulatoryaffairs #mdfundamentals #mdr #ivdr #regulatoryandmore #projectmanagement #visualmaker #projectplanning #makingpresentationsimple

[Regulatory and More @AndRegulatory]

Are you struggling to create a project timeline for your projects?

https://t.co/WshnGooc9o

#medicaldevices #invitrodiagnostics #regulatoryaffairs #mdfundamentals #mdr #ivdr #regulatoryandmore #projectmanagement #visualmaker #projectplanning #makingpresentationsimple

[Regulatory and More @AndRegulatory]

title = "IVDR DoA - Damned I missed it"
project = "Going on https://t.co/3YLevsTYaK"
project ="Choosing the Project Timeline Creator"
project ="Writing this EU Regulatory Strategy asap"
#medicaldevices #invitrodiagnostics #regulatoryaffairs #mdfundamentals #projectmanagement

[Regulatory and More @AndRegulatory]

Project Timeline Template available Now ! Give it a look on https://t.co/ywN758HmPx or on https://t.co/a7FhXYkMo4. #medicaldevices #invitrodiagnostics #regulatoryaffairs #mdfundamentals #regulatoryandmore #projectmanagement #visualmaker #projectplanning #makingpresentationsimple

[Regulatory and More @AndRegulatory]

Proud to announce you a new partnership with the team of VisualMaker! Follow us! More to come. #medicaldevices #invitrodiagnostics #regulatoryaffairs #mdfundamentals #ivdr #regulatoryandmore #projectmanagement #visualmaker #projectplanning #makingpresentationsimple

[Regulatory and More @AndRegulatory]

Our last blog post: IVD Product Types: RUO, IUO, GPR, ASR

See it on https://t.co/j2eOQEHqlR

https://t.co/dOaGODaYff

#medicaldevice #medicaldevices #ivd #ruo #iuo #gpr #asr #invitrodiagnostics #regulatoryaffairs #mdfundamentals #regulatoryandmore

[Regulatory and More @AndRegulatory]

Available now on the Shop!

Template – Product Qualification and Classification under the EU IVDR 2017/746

Give it a look on https://t.co/j2eOQEZ1Kr

#medicaldevices #invitrodiagnostics #regulatoryaffairs #mdfundamentals #ivdr #regulatoryandmore

[Regulatory and More @AndRegulatory]

Available now on the Shop! ISO 13485:2016 Internal Audit Checklist

Give it a look on https://t.co/j2eOQEZ1Kr

#medicaldevices #invitrodiagnostics #regulatoryaffairs #mdfundamentals #iso13485 #regulatoryandmore

[Regulatory and More @AndRegulatory]

Today only! 50% off on our Gap Analysis Tool QSR vs ISO 13485:2016.
Give it a look on https://t.co/j2eOQEZ1Kr and Happy Friday!
https://t.co/L4xTMfzJaR
#medicaldevices #invitrodiagnostics #regulatoryaffairs #mdfundamentals #regulatoryandmore #regulatoryfridaysales

[Regulatory and More @AndRegulatory]

Available now! Word Template – Master Software Validation Test Plan according to FDA.
Give it a look on https://t.co/j2eOQEZ1Kr

https://t.co/lRQHWVS3tM

#medicalsoftware #medicaldevices #invitrodiagnostics #regulatoryaffairs #mdfundamentals #regulatoryandmore

[Regulatory and More @AndRegulatory]

#medicaldevice #medicaldevices #ivd #ceivd #ivdr #ivdriscoming #invitrodiagnostics #regulatoryaffairs #mdfundamentals #regulatoryandmore

[Regulatory and More @AndRegulatory]

Template Word – Technical Documentation Table of Content according to the IVDR (v.1.0) https://t.co/Jw1Noigcyb

[Regulatory and More @AndRegulatory]

Available now! Standard Operating Procedure (SOP) Word Template for Technical Documentation according the IVDR.
Give it a look on https://t.co/j2eOQEZ1Kr

https://t.co/QScKeNjN7Y

#medicaldevice #ivd #ceivd #ivdr #invitrodiagnostics #regulatoryaffairs #regulatoryandmore

[Regulatory and More @AndRegulatory]

What are the fundamental distinctions between an IVD product and a RUO product?
See our post on https://t.co/j2eOQEZ1Kr
https://t.co/ULrCfpoQPd
#medicaldevice #medicaldevices #ivd #ruo #ceivd #invitrodiagnostics #regulatoryaffairs #mdfundamentals #regulatoryandmore

[Regulatory and More @AndRegulatory]

The Investigational Device Exemption (IDE) - 21 CFR 812

https://t.co/OWQavIn1Bw

Check the post on https://t.co/Mqk9cIN9Ic

#medicaldevice #medicaldevices #ivd #invitrodiagnostics #regulatoryaffairs #mdfundamentals #regulatoryandmore #ide #fda

[Regulatory and More @AndRegulatory]

Conformity Assessment Options for Products Failing under the MDR

https://t.co/tlt9K44JZd

#medicaldevice #medicaldevices #ivd #invitrodiagnostics #regulatoryaffairs #mdfundamentals #regulatoryandmore #ivdr #mdr

[Regulatory and More @AndRegulatory]

The WEEE Directive, the RoHS2 Directive, the REACH Regulation and other requirements beyond the MDR and the IVDR

https://t.co/RLvjwnIQWF

#medicaldevice #medicaldevices #ivd #invitrodiagnostics #regulatoryaffairs #mdfundamentals #regulatoryandmore #ivdr #mdr

[Regulatory and More @AndRegulatory]

Trend Reporting under the MDR and the IVDR

MDR Art. 88/ IVDR Art. 83

https://t.co/y8wPBeI0KP

#medicaldevice #medicaldevices #ivd #invitrodiagnostics #regulatoryaffairs #mdfundamentals #regulatoryandmore #ivdr #mdr #trendreporting

[Regulatory and More @AndRegulatory]

Procedure for Dealing with Devices Presenting an Unacceptable Risk to Health and Safety under the MDR and the IVDR

MDR Art. 95/ IVDR Art. 90

https://t.co/Zyizd1Q4gg

#medicaldevices #ivd #invitrodiagnostics #regulatoryaffairs #mdfundamentals #regulatoryandmore #ivdr #mdr #risk

[Regulatory and More @AndRegulatory]

Evaluation of Devices Suspected of Presenting an Unacceptable Risk or other Non-Compliance under the MDR and the IVDR

MDR Art. 94/ IVDR Art. 89

https://t.co/BBwma0qcQx

#medicaldevices #ivd #invitrodiagnostics #regulatoryaffairs #mdfundamentals #regulatoryandmore #ivdr #mdr