Informational Health Canada guidance document – Pre-market Requirements for Medical Device Cybersecurity

SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Informational Health Canada – Notice: Revisions to the Guidance Document: Management of Applications for Medical Device Licences Medical Device and FDA Regulations and Standards News 0
L Medical Device Accessory - Health Canada guidance / definition on what an accessory is Canada Medical Device Regulations 3
M Informational Health Canada – Guidance Document: Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing Medical Device and FDA Regulations and Standards News 0
M Informational Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format Medical Device and FDA Regulations and Standards News 0
M Health Canada Private Label Guidance Confusion - Quality System Required? Canada Medical Device Regulations 5
T Health Canada Class III/IV "Significant Change" guidance interpretation Canada Medical Device Regulations 2
bio_subbu Health Canada's guidance on Class IV Device Electronic Premarket Review Submission Canada Medical Device Regulations 0
M Medical Device Indications for Use Health Canada Canada Medical Device Regulations 6
Edward Reesor Impact of Health Canada Summary Reports Canada Medical Device Regulations 4
T Emailing Health Canada - response time? Canada Medical Device Regulations 3
S Submit to Health Canada with only MDSAP report? Canada Medical Device Regulations 5
B Health Canada Submission Canada Medical Device Regulations 2
B Health Canada - Blood Glucose Meter Registration Canada Medical Device Regulations 0
M Is it Necessary to Use Health Canada Form when Reporting? Canada Medical Device Regulations 1
Z NHP Health Canada Private Labelling Other ISO and International Standards and European Regulations 4
M Quality management certification required by Health Canada Canada Medical Device Regulations 3
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
N Medical Device Misclassified by Health Canada Canada Medical Device Regulations 2
M Informational Health Canada – Drug and medical device highlights 2018: Helping you maintain and improve your health Medical Device and FDA Regulations and Standards News 1
M Informational Health Canada – Mandatory reporting requirements for hospitals Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada launches consultations to improve the safety of medical devices Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada – Fees for Drugs and Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada advises Allergan of its intent to suspend its licences for Biocell breast implants as a precautionary measure Medical Device and FDA Regulations and Standards News 0
M Different websites for different markets - FDA, Health Canada or other requirements Medical Information Technology, Medical Software and Health Informatics 4
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada begins release of clinical data Medical Device and FDA Regulations and Standards News 0
E How do you identify what standards a country recognizes outside of FDA, EU, Health Canada Other Medical Device Related Standards 1
S Health Canada's Action Plan on Medical Devices - 2019 milestones Canada Medical Device Regulations 0
M Medical Device News Health Canada – Consultation: Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
M Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management Canada Medical Device Regulations 1
M Medical Device News Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 Canada Medical Device Regulations 0
M Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan Canada Medical Device Regulations 2
M Medical Device News Health Canada update - Applications for Medical Device Investigational Testing Authorizations Canada Medical Device Regulations 0
M Medical Device News Health Canada - Proposed Changes - List of Recognized Standards for Medical Devices Canada Medical Device Regulations 3
M MDSAP Transition - Health Canada Website Notice on Apr 13 2018 Canada Medical Device Regulations 1
M Medical Device News Health Canada Update - 05-09-18 - Pilot Device Advice Canada Medical Device Regulations 0
M Medical Device News Health Canada update 28-08-18 - Licensing Requirements for 3D-Printed Devices Canada Medical Device Regulations 0
R Medical Device License - CMDCAS certificate release - Health Canada Canada Medical Device Regulations 0
J Health Canada Field Action/Recall MDR Requirements Canada Medical Device Regulations 9
Edward Reesor Health Canada to increase PMS requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
F Health Canada Registration : Company and/or 3PL ? Canada Medical Device Regulations 2
J Revised MDSAP Audit Model - Health Canada - October 30, 2017 ISO 13485:2016 - Medical Device Quality Management Systems 7
L Health Canada email re fee proposals sent to group - driving me mad! Canada Medical Device Regulations 3
S Medical Device License Renewal (MDL) Period - Health Canada Canada Medical Device Regulations 6
B Health Canada Recall Definition - Seeking Clarification Canada Medical Device Regulations 5
M Medical Device Accessories - Health Canada - CMDR Section 21 Canada Medical Device Regulations 1
S Reclassification of a Medical Device by Health Canada Canada Medical Device Regulations 4
Q "Documented Procedure" Health Canada Canada Medical Device Regulations 8
JoCam Format of Health Canada pre-market licence application Canada Medical Device Regulations 3
B Processing Time for a new Health Canada Class II Medical Device Licence Application Canada Medical Device Regulations 3

Similar threads

Top Bottom