Medical Device Safety Assurance Case Reports

R

rjmeader

#1
#1
Hi,

Does anyone have experience with Safety Assurance Case Reports as required for some medical devices (such as infusion pumps)? If so, who in your organization has responsibility for leading this effort? R&D, Quality, other? Thanks.
 
Paper to QMS ad
Elsmar Forum Sponsor
M

Marcelo

Inactive Registered Visitor
#2
#2
Re: Safety Assurance Case Reports

Safety assurance cases are another way to show that you manage risks - meaning, they are part of risk management. Both are expected to be performed (and be the responsibility of) by a multifunctional team.
 
R

rjmeader

#3
#3
Re: Safety Assurance Case Reports

Totally agree. But who really leads the effort (has "responsibility")? There has to be "ownership" by one function/individual otherwise it will likely flounder.
 
M

Marcelo

Inactive Registered Visitor
#4
#4
Re: Safety Assurance Case Reports

Well, that?s a little more difficult.

In my opinion, it would have to be with the risk manager, but most manufacturers still do not have that role.

Anyway, it still should be the leader of the risk management team, so whatever function you put as the head of that team, it should be it. In my opinion, it would need to be someone from R&D (lot?s of manufacturer put this into quality but really risk management has nothing to do with quality).
 
Last edited:
R

rjmeader

#5
#5
Thanks,

Again, totally agree. Unfortunately in some small medical device companies it just seems to fall to whomever picks up the baton and runs with it. R&D may not have the background, skills or motivation to take it on. Quality may be the next logical choice. If neither picks up the baton then Regulatory may somehow fee obligated to do something as ultimately they have to develop a submission.

Wonder what others think.
 
Y

yodon

Staff member
Super Moderator
#6
#6
Marcelo is right (as usual) and there's no 'guidance' on who should lead. Really (as with every role), it boils down to who has the skills (experience / training) to lead.

It's a substantial amount of work to build the assurance case so don't think someone can pick it up and knock it out in a few hours. And, as Marcelo points out, you'll want participation from stakeholders (it can't be done in isolation).

One approach is to outsource the leadership role to someone who does have the experience. Contracting someone with a few notches in their belt may be cheaper in the long run as they will know how to optimize the process.
 
R

rjmeader

#7
#7
Thanks Yodon,

Yes it is a tremendous amount of work. I have done it wearing the Regulatory/Quality hat. Now as a consultant it is interesting to see how others are handling this. Very company has to find out what works best for them. Hopefully they have at least one person that steps up to the plate. Its important to have that ownership that a contractor may not realistically be able to provde.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 8
M Informational Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Proposed changes to medical device essential principles for safety and performance Medical Device and FDA Regulations and Standards News 0
D Electrical Safety During Medical Device Development IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
I Company Safety Officer required for a German subsidiary of a Medical Device Organization? EU Medical Device Regulations 4
A True purpose of doing EST (Electrical Safety Test) on medical device Other Medical Device Related Standards 3
M FDA News USFDA Final Rule – Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures Medical Device and FDA Regulations and Standards News 0
M Medical Device News Medical Device Directives – New templates for Field Safety Notices published Medical Device and FDA Regulations and Standards News 0
G Electrical Safety standard for medical device not covered by IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Electrical safety (battery-powered medical device) EU Medical Device Regulations 1
C FOS (Factor of Safety) Medical Device Other Medical Device and Orthopedic Related Topics 4
L Medical Device Electrical Safety Standards - Gap Analysis of Latest Revisions Other ISO and International Standards and European Regulations 2
F Power Cord Length Issue - Medical Device Electrical Safety IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S FDA Class I Medical Device Safety and Efficacy Data Requirements Other US Medical Device Regulations 5
J Safety and Efficacy study for a medical device in US Other US Medical Device Regulations 5
N Regulatory and Safety Standards for Medical Device with Measuring Function IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
S Medical Device Aging & Safety Questions by FDA Other US Medical Device Regulations 6
T Safety and Effectiveness of Medical Device - What evidence needed? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Li Ion battery for medical device: transportation safety Other Medical Device Related Standards 2
D Recall, Safety Notice or Training? - Medical Device with two identical complaints 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
Sidney Vianna ISO/IEC Guide 63:2012 - Medical Device Safety Aspects Other Medical Device Related Standards 1
G Margin of Safety for Medical Device Fatigue Testing Reliability Analysis - Predictions, Testing and Standards 5
A Medical Device Safety Alert equal to a Recall? Other US Medical Device Regulations 3
W Safety Assurance Case Report for a Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q What about the Medical Device Electrical Safety of LVAD ? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T Safety Classification in Medical Device Standalone Software IEC 62304 - Medical Device Software Life Cycle Processes 26
Y Acceptable Fatigue Safety Factor for Testing Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 2
somashekar Follow-up audit after safety mark authorization (Medical device) ISO 13485:2016 - Medical Device Quality Management Systems 2
P Version of Medical device safety standard - IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
L Question: outsource medical device electric safety test to OEM supplier ISO 13485:2016 - Medical Device Quality Management Systems 3
M Medical device safety and biomedical engineering blog Book, Video, Blog and Web Site Reviews and Recommendations 2
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 7
T Loaded spring device - Active medical device? EU Medical Device Regulations 1
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 2
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
F Labelling requirements for a medical device containing fragrance allergens EU Medical Device Regulations 3
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S The US FDA requirements on Disposal of a medical device US Food and Drug Administration (FDA) 1
Similar threads
Top Bottom