What is ISO 13485 for medical devices? 

Thank you Riaz. This is a good recommendation if you are fluent in English. The vast majority of my viewers have English as a second language.

That's exactly the speed I listened to it at. I could do 1.75x, but I was also doing something

You would do best to contact a local certification body where you are.

John, The answer to this question depends on answers to the following questions. - Are you marketing the medical devices that you sell? What claims do you make in your marketing and can you show evidence that the medical device actually satisfies those claims? - Are you providing any training regarding installation, set up and configuration, operation or maintenance of the device? - Are you providing after-sales support of any kind? - How do you handle and track customer complaints? - How do you track and handle recalls? - Do you do any kind of inspection or sampling to ensure that the devices you receive function correctly before shipment or collection of the device? - Are the medical devices approved for import and sale by you in the country in which you operate? - What is the medical device classification in your country of operation? - Are you registered with a healthcare regulator as an importer/distributor? What healthcare laws and regulations are you subject to? How do you demonstrate compliance? - What due diligence have you conducted to qualify and approve the manufacturer and supplier of your medical devices? - What technical or professional competence is required or expected of your staff? Do they actually have the required training or experience? - To the extent that any of the above apply to you, what processes do you have in place to ensure quality and compliance? - What records can you show as evidence of quality, consistent conformity with the above answers or compliance with healthcare regulations? These questions and their answers are all relevant to ISO 13485:2016. I am sure other people in the industry could think of still more questions. I hope this helps?

Thanks for asking this question, John. I used the opportunity to blog my response: tcmc-qms.blogspot.ca/2016/09/is-iso-134852016-applicable-to.html

Thanks for the response. The answers are the following: - Are you marketing the medical devices that you sell? What claims do you make in your marketing and can you show evidence that the medical device actually satisfies those claims? USING THE MANUFACTURER'S MARKETING MATERIAL - Are you providing any training regarding installation, set up and configuration, operation or maintenance of the device? INSTALL OURSELVES AND DO PROVIDE TRAINING - Are you providing after-sales support of any kind? YES, FULL SUPPORT - How do you handle and track customer complaints? HAVE A CRM SYSTEM - How do you track and handle recalls? USING THE CRM SYSTEM - Do you do any kind of inspection or sampling to ensure that the devices you receive function correctly before shipment or collection of the device? DEVICES ARE TESTED ON ARRIVAL - Are the medical devices approved for import and sale by you in the country in which you operate? YES - What is the medical device classification in your country of operation? DEPENDS, CAN BE B/C/D - Are you registered with a healthcare regulator as an importer/distributor? What healthcare laws and regulations are you subject to? How do you demonstrate compliance? YES - What due diligence have you conducted to qualify and approve the manufacturer and supplier of your medical devices? MUST HAVE CE MARK AND/OR PROOF OF COMPLIANCE - What technical or professional competence is required or expected of your staff? Do they actually have the required training or experience?SUPPLIER TRAINED AND CERTIFIED - To the extent that any of the above apply to you, what processes do you have in place to ensure quality and compliance? INSTALLING QMS - What records can you show as evidence of quality, consistent conformity with the above answers or compliance with healthcare regulations? THAT IS WHAT WE ARE TRYING TO FIND OUT

There is no requirement for a manufacturer to get ISO 9001 first.

That's because this is not ISO 9001; it is ISO 13485

ISO 13485 is for manufacturers of medical devices. Does your hospital biomedical engineering dept actually manufacture medical devices? If yes, then the hospital could seek certification to ISO 13485 for the scope of its medical device manufacturing. Your hospital is, presumably, already registered with your local regulatory body. Don't they require some form of certification of compliance to a standard? You would do best to contact a local accreditation/certification body where you are.

tcmc Quality Management Services Hi Terry Thanks for your responds! The scope of iso13485 says if you are involved in one or more stages of the life cycle, including design and development , production, storage and distribution , installation or servicing a medical device.... As the service and storage is one of the items , I think hospitals Biomed dept should get it and would be the best work frame for hospitals What do you think? Thanks Maryam

@@maryammirjafari2716 hospitals don't need such certification.. it's meant for companies, that produce medical devices.

better focus the content

On its own, ISO 13485:2016 is a set of requirements for voluntarily meeting an international standard for manufacturers of medical devices. One of the requirements is a commitment by the organization to be compliant with local laws and regulations pertaining to medical devices and which are to be identified in the scope of the organization's QMS Quality Manual. These regs will obviously vary from country to country and region to region. In one sense you do not 'need' both, but usually the medical device regulations demand that the organization have a quality management system that must retain certain records and documentation. ISO 13485 is one very good and commonly accepted way to go about this.