Can YOU help? --> Unanswered questions <-- (Other than Marcelo's Informational posts)

class ii medical device

  1. N

    Medical Device Re-Classification

    Hi. I'm hoping someone here can help me out with a question regarding re-classification. We have a Class IIa device that can be connected via Bluetooth to a Class IIb device from a different company. If the firmware of our device tells the Class IIb device to change its operation setting, does...
  2. B

    Class IIB Device - IEC 62304 Software Classification

    Hi all, I have a class IIb medical device (a CBCT scanner for extremities) for only diagnostic purpose; is there a required software classification. The software manages images acquisition, 3D Reconstruction and visualization on the viewer; no further decision is taken automatically. I suppose...
  3. F

    MDR ISO 13485 for Class I sw/hw company to be class II due dates

    Hi, There has been debate about the date we can no longer sell out product in the EU and need to be MDR and ISO 13485 certified. We are currently a Hw/SW device class I self-certified. When will that certification be no longer recognized? 2020, 2022, 2024. I've see multi-dates and wanted...
  4. H

    Safety and efficacy study for CE marking

    Hello, We have a Class IIB medical device which we will be taking to in-vivo trial soon. Obviously there is no straight answer here, but what sample size is generally accepted by EU/US to claim that the device is safe and effective? Many thanks.
  5. Ed Panek

    Other company wants to use our FDA 510K bundled with their product

    We are a class II medical device thermometer that broadcasts Bluetooth to our iPhone or Android phone application. Another company wants to bundle our device with their non-medical non-FDA product using their phone app to show the data. I said we should perform a risk analysis for this along...
  6. P

    510(k) cleared, Rx only and home use

    Hi all, Thank you everyone for all of the posts over the years. I am excited to get involved here and appreciate the advice I've been able to find so far. I am new in my role as a QA/RA and at a medical device startup. I'm looking for help on how we can navigate the question below. We have a...
  7. Z

    Direct Part Marking (DPM) requirements for Class II Medical Devices

    All, I have received conflicting advice on Direct Part Marking (DPM), for Class II devices. Our devices are reprocessed and packaged in a kit. The kit has its own UDI information. For the DPM (DI + PI) does it have to be human readable AND AIDC? Thank you!
  8. kiwi.kczt

    Is Mold qualification / process validation always required?

    Hello, We are outsourcing manufacturing of a injection molded component of a Class IIa medical device to a factory. ISO13485:2016 clause 7.5.6. states: "The organization shall validate any processes for production and service provision where the resulting output cannot be or is not verified by...
  9. M

    Include IFU in Class II Medical Device Marketing Brochure?

    Hi, We have written a 510(k) for a class 2 medical device and submitted the Instructions for Use and the Brochure. The FDA feedback we receive is: Indications for Use (IFU) are not clearly stated in promotional material for the devices. On page 108 (Brochure), it indicates that “The device...
  10. chris1price

    MDR Conformity Assessment for a Class 2a device - Production Quality Assurance

    Hi, I'm hoping someone can double check this for me. I am comparing the conformity assessment routes for a Class 2a device under the new MDR. In particular, comparing Annex IX (full quality assurance) with Annex XI Part A (Production Quality Assurance). As I see it, the key difference is that...
  11. S

    IDE to support premarket submissions

    Hello everyone, I am new to the world of investigational testing. How much weight can we assign to feasibility data in a premarket submission? Can we use feasibility data to support class II applications? For those familiar with Health Canada's regulations, there is a parallel investigational...
  12. S

    Is Lot Number required in addition to UDI serial number?

    We had a very interesting discussion this morning where the team was split in use of both Lot Numbers and UDI serial numbers. We will be having a new Class II medical device where each of the units (these are small units and not huge capital equipment) will have a UDI serial number. These units...
  13. S

    Package performance testing for non-sterile Hydrogels

    What kind of package performance testing would be required for non-sterile, class II medical devices (wound dressing hydrogel)? Any standard or guidelines we could follow (EU or FDA)?
  14. N

    Safety Certification Program?

    Our Class II electromedical device was tested and certified to IEC 60601. We put a little symbol on our box that indicates same. Now our test-lab would like us to pay $1200/year for their "safety certification program", which (I presume) is basically $$$ that allows me to continue to put the...
  15. M

    Annex I - General Safety and Performance Requirements. Precise identity - how provided

    I'm working for a device company with 'a system' that has a range of 30+ attachments., supplied sterile. The system is a Class IIb device and the attachments are used singly as required by the clinician. We are in the process of updating our technical file and creating a STED that addresses the...
  16. B

    Manufacturing site relocation of pre amendment Class II medical device

    Good Day - Trying to determine what a risk analysis would look like for moving our manufacturing process of a pre amendment class II medical device. Thanks in advance for inputs.
  17. H

    Classification of a Class IIb Medical Device with 3 Components

    My company will be a legal manufacturer a medical device. Overall it is classified as a IIb. However, there are three components to it. 1. A generator which delivers a specific type of power to the device 2. A grounding pad which is placed on to the patient (sterile), this is connected to...
  18. R

    Online / Cloud Based Software as Medical Device

    Dear all, Currently I am working on a medical device product which might comprehend an online server. Depending on our strategy this online server might be qualified as a class IIa medical device which has to be approved by a NB. I now had a look if I could find online servers which have a...
  19. A

    DHF File - Shall the document cover all the variants?

    Hi, I want to prepare a DHF file for Class IIa product. This product has more than 70 variants (different specifications). Currently, I am working on the System Requirements Document. Shall the document cover all the variants? or Do I need to segregate them? Because during design...
  20. M

    Virtual Manufacturer vs Reseller (Medical Devices)

    Hi all, I read the many thread about virtual manufacturing of medical devices but could not find the straight answer i was looking for. Maybe starting this thread will help closing once and for all the subject ! My company is going to commercialise medical devices class IIa in the EU. The...
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