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life cycle of a device or product

  1. D

    Lifetime of the Medical Device

    As a medical device contract manufacture, my company is often required to determine the lifetime of a device; however, since we don't hold the 510K or do any post-market surveillance, we are typically dependent on the company placing the device on the market for this information. The problem is...
  2. C

    How long is an OEM obligated to provide spare parts and repair

    My company was an OEM of a medical device for a distributor. Our agreement has since ended. We haven't removed the product from our listings, we just don't manufacture it anymore. How long must we provide repair or spare parts for the device to that distributor? I'm assuming there's a ruling of...
  3. Edward Reesor

    Role of increased regulatory costs in increasing risk

    :notme: Now here's a "fun" discussion topic that came up in our office. I was explaining to our staff how our company is responsible to track the entire lifespan of our product from design to contract manufacturing, shipping, distribution to final disposal - all in the name of patient...
  4. R

    Life Cycle Assessment of a Product

    Can anybody explain in detail with an example of Life cycle Assessment of a product?
  5. A

    Medical Device Handling AFTER the device's specified lifetime has expired

    Hello. Actually I have to deal with discussions about complaint handling... If a medical device is sent back from customer to the manufacturer because of a defect AFTER the device's specified lifetime has expired - is it a requirement to treat this as a complaint acc. §820.198? If yes -...
  6. Ajit Basrur

    New Guideline from ICH proposed on Lifecycle Management - Q12 Q12 - Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management This topic was endorsed by the ICH Steering Committee in September 2014. This new guidance is proposed to...
  7. D

    Testing to determine Life Cycle of a Medical Device

    Hello, I want to test a medical device to determine the life cycle of the device. What standards can I use to test how many uses I can get out of a device? In other words, what standards and tests can I use to determine the expected service life of the device? Thank you in advance for the advice!
  8. N

    Are Overload Test Results expected to be maintained through out Life of Product?

    Hoping someone can help... Here are the facts: We make mechanical (non electrical) Class ! devices. These attach to surgical tables and are used to position patients in the operating room. When we design our products, we do overload testing to a 2.2 factor of safety. We base this testing on a...
  9. Marcelo Antunes

    RAPS RAC - Regulatory Affairs Certification Tips

    Having recently passed the exam for the RAPS RAC certification - GS - Global Scope, i felt it could be great to point out some tips for those who wish to be certified. First i would advise on buying the RAC exam preparation book available in the RAPS bookstore...although expensive, they are...
  10. J

    Requirements for Documenting Lifetime of a Medical Device

    My organization received a non-conformity because the lifetime of the device was not documented. Should this be documented in Sec 7? Should it be an attachment?
  11. Q

    ISO 14971 Class II Medical Devices - Product Realization & Risk Management

    Hi, What will be the RA process flow for the medical devices Class IIa? I am talking about the complete life cycle of the product, and not just the design. Thanks, :confused:
  12. A

    Are Risk Analysis Studies required only for devices, or other processes too?

    The only risk analysis studies (IAW 14971) that we document are for our finished devices, throughout their life cycle. Should we also be conducting risk analysis studies on design, manufacturing and other product realization activities that are not specific to any device? If so, what processes...
  13. R

    Medical Device Contract Manufacturer doesn't know ISO 14971 3.4 a) Life Cycle Phases

    ISO 14971 3.4 a) says the RM plan should include "the life-cycle phases for which each element of the plan is applicable." My company does contract manufacturing, and a combination of both contract engineering and contract manufacturing for medical devices. We do not market the devices and...
  14. A

    Requirement 4 of MDD 93/42/EEC - Definitions of Lifetime, Life Cycle, Shelf Life

    Hi, in one of audit report technical file review of a single use medical device; the technical file reviewer, raised following note against essential requirement 4 of MDD 93/42/EEC: " In response to ER 4 please provide information about the defined product lifetime (not shelf life)." Would...
  15. Marcelo Antunes

    Use of Safety and Process Standards in the Lifecycle of Medical Devices

    Hello all As some of you might know, i´m the chairman of the Brazilian mirror of TC 210 - Quality management and corresponding general aspects for medical devices and i activelly work in other TCs regarding standardization of medical device. We are beginning developing some guidance documents...
  16. O

    Average Life Cycle Duration for a large number of medical equipment types

    Dear all, i remember that any organization issued a table wich contained the estimated life cycle duration for a large number of medical equipment types, but now i am not able to find it again. Someone could provide this document or link to it?. Thanks¡
  17. F

    Medical Device Cleaning Lifecycle test - Developing a Design Verification Spec

    I am currently trying to develop a Design Specification verification of a 15,000 cleaning cycles and no degredation test. In other words after 15,000 cleaning cycles of a Class II Medical Device component (PMA required), will it still operate as designed for its intended use environment. Any...
  18. C

    Material Compliance Management System

    Hi All, I am searching on internet in the last couple of days looking for a material compliance management system of electronics parts i.e the PLM system, what I need is a system that can satisfy the EU regulation such as ROHS,REACH and others to identify all material are compliance at...
  19. F

    Life Cycle Cost worksheet - Reliability and Maintainability of systems

    Good day. This is my first discussion! :0) I am a quality manager with 20+ years experience in a number of manufacturing processes and materials. I hope I can help when needed. I am beginning to get back in to Reliability and Maintainability of systems. I am looking for a LCC...
  20. M

    Life Cycle Cost for Repairable Systems and Weibull Analysis

    Hi, I study Life Cycle Cost for reparable systems. The paper that I read are all about system with constant failure rate. I'm interested to study all Life Cycle of the system, also when Weibull shape parameter (Beta) is > 1. Is there any paper or website that I can visit??? TAL Mattia
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