UL First to Offer ISO 14971 Registration Service

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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: UL issues first ISO 14971 Certificate

The press release: "UL First to Offer ISO 14971 Registration Service for Medical Device Manufacturers Seeking Global Regulatory Compliance

Northbrook, Ill., March 13, 2007 -- Underwriters Laboratories Inc. (UL), a world leader in product safety testing and certification and management system registrations, today unveiled a first-of-its-kind service for the medical device industry that streamlines the regulatory compliance assessment process for manufacturers seeking global market access efficiencies.

"UL's leadership in offering the first ISO 14971 Registration Service is another example of the continuing commitment UL has in providing end-to-end regulatory services for Medical Device Manufacturers and their suppliers," said Anil Patel, General Manager of UL's Medical Business Unit. "As part of the overall regulatory process unique to the medical device industry, this registration supports both the manufacturer's ISO 13485 Quality Management System and the IEC 60601 3rd Edition compliance requirements."

The UL ISO 14971 Registration Service is a continuous assessment of a medical device manufacturer's risk management process that assures compliance with the risk management process requirements of ISO 60601 3rd edition. It also provides confidence that the risk management requirements of regulatory bodies in the U.S., Europe, Japan, Canada and Australia are met.

"Medical device manufacturers want specialized, single-source solutions that accelerate their compliance with the complex global regulatory environment," said Harvey Rudolph, Ph.D., Global Program Manager, Medical Devices. "As the only provider currently offering an ISO 14971 Registration Service, UL can satisfy the customer's needs for conformity assessment to ISO 14971."

UL professionals have expertise in all aspects of regulatory compliance and have been involved in the development of ISO 14971 since 1996. A staff member in UL's Medical Devices Business Unit is the co-author of the ISO 14971 standard.

On-site implementation audits are part of UL's service offering to help customers assess their risk management systems based on ISO 14971. UL also provides private on-site training workshops to assist manufacturer's understanding of the requirements for conformity with ISO 14971.

About ISO 14971

As the only international standard for Risk Management for Medical Devices, ISO 14971 has become an integral element for satisfying regulatory requirements in most major markets and should be incorporated into the medical device life cycle.

ISO 14971 has been formally recognized by the U.S. Food and Drug Administration (FDA) and by Health Canada; the European Union has adopted it as a harmonized standard; Japan has designated it as a Japanese Industrial Standard; and Australia has made it their "de facto" standard for risk management.

The purpose of ISO 14971 is to assist medical device manufacturers in establishing, documenting and maintaining a risk management process to: 1) identify hazards and hazardous conditions; 2) estimate and evaluate the associated risks; 3) control those risks; and 4) monitor the effectiveness of the controls put in place throughout the product life cycle.

ISO 14971 is referenced in a number of other important medical device standards, including the third edition of IEC 60601-1(electrical safety), IEC 60601-1-6 (usability), ISO 13485:2003 (quality) and IEC 62304 (software), among others."
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
Re: UL issues first ISO 14971 Certificate

So Al - What's the scoop?
 

Al Rosen

Staff member
Super Moderator
#5
Re: UL issues first ISO 14971 Certificate

So Al - What's the scoop?
ISO 14971 is a harmonized standard that's not required, but can be used to show compliance to the ISO 13485 Risk management requirements. If you are registered to ISO 13485, you do not need separate registration to ISO 14971. If you read between the lines it's another way to increase revenues. It's like adding the two words "and repeat" to instructions on a shampoo bottle. They are superfluous. Just my opinion.
 
W

wrodnigg

#6
Al, I agree with you.

This is a nice sheet of paper, but no need to register with 14971.
(also certification services need to make money) .oO(maybe we should offer a similar service - just kidding)

Also any 14971-registration would be worth nothing, because I do not know a competent authority that would give an accreditation for 14971-registrations.
(And after accreditation there should be an international recognition...)

So its just a paper to put on the wall or website, but no requirement for design, development and manufacturing of medical devices.

Disclaimer: Just my private opinion :2cents:
 
R

Roland Cooke

#7
Q. What can I say that won't get me into trouble? :mg:
A. Not a lot! :tg:


I would note that UL is historically strong with electro(medical), and I guess the new ISO14971/ISO60601 convergence may have something to do with their seeing a market for this product.

I'll steer clear of this for now, I'll try to answer any direct questions. That said I would be interested in hearing of people's experiences, perhaps via PM if necessary.
 

Al Rosen

Staff member
Super Moderator
#8
Q. What can I say that won't get me into trouble? :mg:
A. Not a lot! :tg:


I would note that UL is historically strong with electro(medical), and I guess the new ISO14971/ISO60601 convergence may have something to do with their seeing a market for this product.

I'll steer clear of this for now, I'll try to answer any direct questions. That said I would be interested in hearing of people's experiences, perhaps via PM if necessary.
Why PM and not open discussion? I would also be interested, as probably would others here.
 
R

Roland Cooke

#9
Thanks Al.

I am certainly not wanting to duck the issue, it is just that I always do try to post in a semi-formal capacity. I say "semi-formal", because I am not writing on behalf of SGS, (legal ramifications etc), but equally I feel it important to identify myself fully to the readers, so they know where I am coming from as a representative of SGS' global medical devices team; equally I also try to offer a basic Notified Body / Registrar perspective on behalf of all those bodies.

Even with those provisos above, it is a bit tricky for me to comment on the ISO14971 side of things. I don't know what UL's market strategy is here, or why BSI have decided to follow suit. It is indeed possible that SGS will take the decision to also offer this service, we are of course studying developments closely.

I am also not an electromed specialist, so I don't know if there is a call for this product for this product from that particular market sector. It may even be a regional thing - I have just moved to the USA, perhaps that is where any demand might be coming from?

As a point in favour of the product, I still find that most companies are pretty poor at incorporating Risk Management throughout their (product realisation element of) quality system, albeit most do a reasonable product-specific risk analysis. So anything that promotes the more effective use of ISO14971 certainly is a plus.


P.S. I found the reference to "safety" :D:notme:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
So anything that promotes the more effective use of ISO14971 certainly is a plus.
That is a good point. Unfortunately, however, there are tremendous amount of anecdotal evidence that many ineffective systems get certified. Especially, under non-accredited schemes where the CB's are not overseen by anybody. So, if the goal is to promote effective use of ISO 14971, maybe certification to it is not the answer.
 
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