medical devices

  1. S

    When medical devices are sold domestically, can they be sold in Puerto Rico?

    I know the answer is a "Yes" but just wanted to confirm that when medical devices are sold domestically, that includes Puerto Rico as well, and that no additional approvals are required to sell a medical device in Puerto Rico? Thank you!
  2. E

    CB scheme applicability for battery powered medical devices

    Can anyone clear up a problem for me - looking at potential CB scheme certification for medical devices that are battery powered, but hearing that not applicable. Only those devices that use a medical power supply (AC to DC) require the CB cert, for the PSU only, and that needs to come from the...
  3. Marcelo Antunes

    Medical Device News BSI achieves Designation for its Netherlands Medical Devices Notified Body

    BSI achieves Designation for its Netherlands Medical Devices Notified Body BSI achieves Designation for its Netherlands Medical Devices Notified Body | BSI Group
  4. supadrai

    What to expect when moving to higher-risk medical devices?

    Hi Everyone, I'm relatively new to medical devices and kind of got thrown into the deep end in March 2017. So far, so good. We only sell medical examination gloves at the moment, so it seems we don't get that much attention from regulators and the processes are not too complex. But what should...
  5. G

    Single DFU for multiple medical devices in one box

    Dear Members I have a question regarding the option of placing only a single DFU (directions for use) in a box containing multiple devices of the same type. In EU, According to the MDD, this is a valid option (Annex I, section 13): "As far as practicable and appropriate, the information needed...
  6. S

    Is Human Factor Testing required as part of Design Control Validation?

    I am not terribly experienced in human factor testing. Is human factor testing required as part of design control under validation? Thank you. I would appreciate any reply.
  7. M

    Contract Manufacturer of a Finished Medical Device

    Hello all. I am relatively new to Quality, so please bear with me. First, a little background: I work for a company that is onboarding a new project. We are currently ISO 13485:2016 certified as a contract service provider for a particular process. This new project falls outside of our...
  8. 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...
  9. S

    Help develop sampling plan for prototype samples (medical devices)

    Hello everyone, I need help on developing sampling plans for prototype samples and am looking for which valid statistical technique to use. Please be kind on me as I am new to Statistics :) Thank you
  10. J

    21CFR820 requirements for Foreign Exporter?

    Could anyone advise if a Foreign Exporter only needs to have their establishment registered with the FDA, or would they need to ensure they have processes in place to follow FDA regulations for medical devices (21CFR820 specifically) as well?
  11. A

    Accelerated aging and real time study

    Hi All Covers, Good day! I am looking for a protocol for accelerated and real time study for Class 1, 2a and 2b medical devices. Does anyone has any related samples/template and could share? In what frequency should a real time study be carried out? Once we completed the real time, should we...
  12. S

    ISO13485 2016 - What the upshot is of failing to upgrade on a medical diagnostic device

    We are looking moving up within the next year from 2003 to 2016 but I am wondering what the upshot is of failing to upgrade on a medical diagnostic device that we manufacture that is sold globally.
  13. K

    Difference between intended purpose and intended use of the device

    Hi, I'm working on IVDR. gone through Annex-XIII, in which it is mentioned that "specification of the intended purpose of the device; and specification of the intended use of the device" to be mentioned in performance evaluation. Whether intended purpose and intended use is different...
  14. C

    Lithium battery powered Medical Device - 15.3.3 Impact test, broken enclosure

    Hello everybody, I'm a long time reader of the forum and this is my first post. We are developing a body worn, lithium battery powered, medical device. Think of it like a wearable headset + pocket unit. After undergoing the impact test of 15.3.3 (which, by the way, seems quite hard as...
  15. D

    Do Test Methods completed to a standard require validation?

    My company designs and manufactures wound dressings. We complete a range of dressing adhesion and moisture absorption tests that are taken directly for a an ISO standard, do these require validation under 13485? Any suggestions welcome.
  16. C

    Medical Device Molded Parts with Text on Them

    I hope someone can help. We have some molded parts for a medical device that have a number of bits of descriptive text on them. My question is "Is this considered to be "labeling" and if it is, is it subject to the requirements to translate under the MDR." Looking forward to some advice...
  17. C

    QR Code on Medical Device Packaging and Notification to Notified Body

    Dear All, I have a question related to the reporting of MD changes to notified body. The manufacturer wants to introduce a QR code to the packaging of the medical device. The QR code refers to a video in which the MD is presented and the mode of use is explained. This information reported in the...
  18. S

    Should the Label for Serviced Medical Devices be Replaced?

    Hi Fellows, A client of mine recently replaced a Notified Body and a question arose: Should they replace the device label to show the new NB number whenever they receive a devices for service & repair? It seems like a 'gray area' although it makes sense to do it, but the logistics effort is...
  19. P

    Special 510(k) - Modified Medical Device Description

    Hey, guys! This is my first time preparing a special 510(k) and I went through all related topics and guidelines to find the things that are bothering me and I seem to be stuck on one particular - description of the modified device. In the first submission (I wasn't working here back...
  20. J

    One Medical Device, two indications, two classes, one technical file?

    If a manufacturer has one device that is sold with two different indications for use and one is a class I and the other a class IIa, can they have the same technical file with two different classifications with all documents in the tech file referencing both devices? The only document they would...