Application of Risk Management - ISO 14971:2007(E) Medical Devices

Al Rosen

Staff member
Super Moderator
#41
Re: ISO 14971:2007(E) Medical devices — Application of risk

Ironically, the document that started this post (posted by my co-worker, a great team member) has been retired. Our organization recently integrated risk analysis and design control into one process (which is probably the intent of the standard)

The core idea behond Risk Analysis & Management is:

At each stage of product development (from concept to post-market) you must say "what are the risks", "are there any dangers", "what can go wrong", and "how can someone make a mistake.

If you find a potentional hazard you must say, in the following order, "can we reduce this by changing the design (round instead of sharp edges)", "can we reduce this by some protective measure in the device or manufacture of the device (like an alarm in the device)", and "can we reduce this with information (warning label or good instructions for use)"

Finally, you must document when you asked yourself these questions, what the answers were .

There are many ways you can do this but the way you document should be suited to your organization's needs and resources.
Risk management extends past the design stage to production and user experience.
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#42
If, for design controls, you mean "the whole quality system", you´re right, ISo 14971 was meant to be integrated in your quality system.

Anyway, as Al said, and i´ve said before, ISO 14971 is a lifecycle standard, meaning that it is to be used in every stage of the product life. The whole problem is that "design controls", and other similar regulatory requirements, are usually focused on the design process and begin on the "design input" phase. So, interestingly enough, people tend to use the standard just for the "compliance to regulatory requirements" part of it.

I´m just finishing the making of a training in which i try to go "beyong compliance" with risk management and it´s real difficult to find material and cases in which risk management is REALLY used through the lifecycle.
 
Q

QA-Man

#43
Re: ISO 14971:2007(E) Medical devices — Application of risk

Risk management extends past the design stage to production and user experience.
My post was only meant to express the core idea. However I did say from concept to post-market. :notme:
 

Al Rosen

Staff member
Super Moderator
#44
Re: ISO 14971:2007(E) Medical devices — Application of risk

My post was only meant to express the core idea. However I did say from concept to post-market. :notme:
I must have misunderstood the statement about integrating the risk analysis & design control into one document.
 
C

cf252

#47
Nothing is risk free (or can be proven to be so), however, I quite like the pragmatic approach to risk taken by the United Kingdom General Product Safety Regulations 2005, which maintain the general duty placed on producers and distributors to place on the market (or supply) only products that are safe in normal or reasonable foreseeable use. These regulations then actually define a ‘safe product’ as:

“"safe product" means a product which, under normal or reasonably foreseeable conditions of use including duration and, where applicable, putting into service, installation and maintenance requirements, does not present any risk or only the minimum risks compatible with the product's use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons. In determining the foregoing, the following shall be taken into account in particular—

(a) the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, instructions for installation and maintenance,

(b) the effect of the product on other products, where it is reasonably foreseeable that it will be used with other products,

(c) the presentation of the product, the labelling, any warnings and instructions for its use and disposal and any other indication or information regarding the product, and

(d) the categories of consumers at risk when using the product, in particular children and the elderly.

The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to be a dangerous product;”

The regulations do not expect nuclear plant operators to turn off the main cooling pumps to the reactor, they do not assume parents to place a baby seat on a high surface and leave the child unattended etc. They assume normal or reasonably foreseeable use - not acts of sabotage or stupidity.

In some cases it is the Courts who decide what is safe or not and this can lead to odd results eg. the Police officers who risked their lives and shot dead a suspected bomber in London were prosecuted for being in contravention of Health & Safety Regulations!

It is an ideal to start integrating safety at the conception stage of a project but sometimes you are just presented with a fait accompli and have to 'backfit' a safety analysis to an existing product. This can be useful in uncovering information, or the lack of it, and helping to reduce commercial risk in addition to quantifying consumer risks.

HAPPY NEW YEAR from the UK!
 
Last edited by a moderator:

Marcelo

Inactive Registered Visitor
#48
Last edited:
C

CBAL08

#49
I am in the earlier stage of the risk management procedure for medical device and would like to be on the right way from the start.
Could anyone send Risk Management File template or any related document?
Thank you
 
W

Watchwait

#50
Like many others, I've reviewed all the postings here, as well as any examples and attachments herein. The best I've seen to-date are examples of hazard analyses, some with actual traceability to appropriate test results. We have also performed this exercise and have produced a complete hazard analysis.

As a side note, we had our testing agency perform a gap analysis for compliance to IEC 60601-1 3rd Edition. Risk management is a key element of this new edition & ISO 14971:2007 is continually referenced in the 3rd edition.

Our "reviewer" indicated that our hazard analysis, though quite extensive, did not meet the requirements of a full-on risk management file as required by the 3rd edition. I have reviewed both the 3rd edition of 60601-1 & 14971:2007 and believe that we likely have all the information required to complete the file.

However, this this one of those "projects" where, without SPECIFIC formatting guidance (read: templates) we are likely to spend an inordinate amont of time trying to figure out how to present the information required. Clearly, this is more than "just do what's best for your business & everything will be fine".

Also, I notice there have been over 14,000 hits to this thread, which must be indicative of the dire need for some specific samples, templates, anything that will help facilitate creating a Risk Management File that will meet requirements. Given 14k+ hits, I'm betting that by now some kind soul will offer up a nice, tidy set of templates that once filled out will do the job! Data I can provide - formatting I'll leave to the....formatters!:)
 
Thread starter Similar threads Forum Replies Date
B Application of Risk Management - ISO 14971 for a Tooling Manufacturer ISO 14971 - Medical Device Risk Management 18
V ISO 14971:2007 Application of Risk Management to Medical Devices ISO 14971 - Medical Device Risk Management 9
J FMEA "Types" - ISO 14971 (Medical Devices - Application of Risk Management) ISO 14971 - Medical Device Risk Management 7
I Fault Tree Analysis (FTA) - Application - Preventive, Corrective or Risk Analysis? Quality Tools, Improvement and Analysis 10
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 0
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
G Application to Chartered Quality Institute - MCQI ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
supadrai Possible to Submit a 510(k) if you have never, do not and cannot produce the device for which you're submitting the application? US Food and Drug Administration (FDA) 4
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 1
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
U GMDN CODES application ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Monolithic application and medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
R CAMBODIA - Application of AMDD Other Medical Device Regulations World-Wide 3
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
T Commission proposal being drawn up for postponement for date of application of MDR (2017/745) EU Medical Device Regulations 7
N Program or application for standard time measurement in industry from video surveillance? Human Factors and Ergonomics in Engineering 1
J Are DAM tools, Mobile application, clinical dashboard, etc. considered accessories to medical device or supportive functions? Manufacturing and Related Processes 4
J Application of mains voltage on SIP/SOP connectors of medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
P SOUP anomaly evaluation for MMA (Mobile Medical Application) IEC 62304 clause 7.1.3 IEC 62304 - Medical Device Software Life Cycle Processes 6
M Informational TGA presentation: How to submit an effective good manufacturing practice clearance application Medical Device and FDA Regulations and Standards News 0
C ISO 9001:2015 Monitoring and measuring resources. Application a service industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Z Role of economic operators (EO) post the EU MDR Date of application in May 2020 EU Medical Device Regulations 1
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Informational EU – Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC Medical Device and FDA Regulations and Standards News 2
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
A Validating my own application developed with Agile Qualification and Validation (including 21 CFR Part 11) 5
M Informational EU – Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council o Medical Device and FDA Regulations and Standards News 2
Sidney Vianna Informational ISO 18091 - Guidelines for the application of ISO 9001 in local government Other ISO and International Standards and European Regulations 1
S Internal Audit Checklist for Application/Software development IEC 27001 - Information Security Management Systems (ISMS) 1
M Informational MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017 Medical Device and FDA Regulations and Standards News 0
D I'm new in IMDS special using the IMDS application Manufacturing and Related Processes 8
M Medical Device News NB-Med and Team-NB have jointly edited a white paper entitled “White Paper – One Year of Application” Medical Device and FDA Regulations and Standards News 0
S IATF 16949 9.1.1.3 Application of statistical concepts - Our technicians are quizzed for statistical knowledge IATF 16949 - Automotive Quality Systems Standard 3
supadrai Informational Japan Minor Change Notification Application Form - Found it? Japan Medical Device Regulations 0
M Some possible misunderstandings on the application of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 10
K Need feedback: FMEA Web Application FMEA and Control Plans 5
I FAR Part 43 and Application to 17025 Accredited Cal Lab Federal Aviation Administration (FAA) Standards and Requirements 2
B Request for Information; Application for Accreditation Japan Medical Device Regulations 0
Y Application of IEC/EN 62304 at an advanced stage of software development IEC 62304 - Medical Device Software Life Cycle Processes 4
M What is considered an "Audit Day" for OASIS AEA application? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Ajit Basrur CDRH Premarket Approval Application Critical to Quality Pilot Program US Food and Drug Administration (FDA) 0
Sidney Vianna Blockchain Technology - Any examples of practical application? The Reading Room 21
V Delete Restrictions to be enabled AT BOTH Operating System & Application Levels Qualification and Validation (including 21 CFR Part 11) 1
R Is it legal to attend a trade show while you have a 510(k) application pending? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Zinc Oxide as a Topical Application EU Medical Device Regulations 4
C Application of ISO 9001:2015 Clause Interpretations for Service Industries Service Industry Specific Topics 2

Similar threads

Top Bottom