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What sections of ISO 13485 cover computer systems?
Would like to know what sections of ISO-13485 cover computer systems or is it another standard? -
Auditing according to section 8.2.2
I've been asked to conduct a 13485 audit specific to complaint handling. Would I only need to audit according to section 8.2.2? Thank you! -
IEC 62366-1 question
Hi Kristina – is this standard only applicable to medical devices with computer/software components? If so, is there a different usability standard that pertains to non-computer related medical devices ? -
Guidance for dealing with "old" devices
We have been marketing our devices in the EU since 2011 and have records and survaillance of these Class I devices since that time. These devices are cleansing devices for the eyelid, eyelashes and area around the eye but not for the eye itself. We also market a device called *** whose active ingredient is Tea Tree Oil in very low quantity or percent concentration. According to the guidance for Legacy devices MDCG 2021-25 issed October 2021, these devices are not considered "New' devices (devices to be submitted under the MDR and new to the EU market) nor or they considered " Legacy" devices (devices who were introduced to the market during the development of the MDR but before May 26, 2021. Our devices according to this guidance are considered "OLD" devices and defined as those devices that were placed on the market before 26 May 2021 in accordance with the AIMDD or the MDD or in accordance with the applicable rules before the directive had entered into force. . Is there a guidance for these "old" devices. -
Question-MDR
We are preparing our "Technical Documentation" documents for Class I products. Our partner company provide us the attached GSPR form which should be filled out for each product. But I did not find such form in the documents I purchased from you. I guess, we have a new document instead. Can you please let me know which document should be used as GSPR for Class I products? -
MDR submission
Hi we are a new medical device manufacturer, preparing for our MDR submission. For our samples, do the sample need to be like how it would be i.e. with design, brand name, labels, product description with translation of different languages, and EC Rep? -
Classification of medical devices
I have a question which is bothering me regarding the classification of medical devices, and what would be regarded as a medical device. I have a client who assembles and sells X-Ray systems. All the parts, apart from some of the mechanical parts are imported from various suppliers and assembled into a single system here in South Africa. The mechanical parts (X-Ray table, Bucky stand and tube stand) are manufactured locally. Are they to be regarded as medical devices in themselves, or are they only components of the completed system? I am thinking that the X-Ray table has no medical device function before it is assembled into a X-Ray system. The same applies to locally built trailers which are used to install occupational health system and X-Ray systems into which are used as mobile units, especially in rural areas, Surely the trailer is not a medical device. My thinking is that the mechanical components do not need a separate medical device file, but can be included as component parts in the X-Ray system medical device file. Or am I seeing this completely wrong? -
Do we need MDR?
We are a small Bee spoke company who manufacture Seating/backrests for Wheelchairs we buy in. I am trying to find out what our requirements are for MDR. if any? -
Facilitating training of medical devices organization for their management
My question is do I need to be certified to ISO 13485 to facilitate training of medical devices organization for their management since I have been a lead auditor and have great third party certification and implementation experience? -
Technical documentation of medical device class IIb
which are all the documental requirements I must give the notify body for can submit successfully a medical device class IIb that has a chanche of material? which are the principal points that you could give us as a tip to be more focus in order be correct a CEP, CER, RMP, RMR, BER.? What is the biggest tip that you can give me in order to know which laboratory test I must do to medical device? It´s possible that with scientific articles that talk about specific device I can substitute the laboratory test of medical device? which could be the legal base in order to can justify this?