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  • 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?
  • Mock examples

    my question is we presently do not have business requiring 13485 however our registrar expects we have examples. We have many medical parts and more to come after we are certified.. I plan to set up a mock examples of how we would handle medical devices with the current parts we have. do you feel this is a good approach to demonstrate our readiness?
  • Clinical Evaluation Plan

    I have a task to complete to comply with MDR. My first priority is to write up a Clinical Eval Plan and then get it approved before starting the evaluation process. Question is what is a typical format would you recommend to use? This would be a Class 1 non invasive medical device that will be distributed in European countries.
  • FDA

    We are not a manufacturer of medical devices; we have designed and built a ventilator that we intend to submit to FDA for EUA approval. It is a novel design which has several advantages over current ventilators and is patent pending through PCT; two questions for you: 1.  Does the EU has also an emergency use authorization as FDA does for medical devices, specifically ventilators? 2. Are you familiarized with the process for EUA Authorization of the FDA?
  • Microbiology Lab for Implants (Plates and screws)

    Could you please help me to understand the requirements for the microbiology lab requirements for Orthopaedic Implants (Screw, Plates and Knees) to be complied with ISO 13485 and MDR 745 Requirements.
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