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  • Is there a requirement for periodically documents review?

    per ISO 13485, is there a requirement for periodically documents review? and if so, what is the scope (containment) of it? Does it apply to all controlled documents ( QMS Procedures/forms, SOPs, Work instructions, etc.. ) or only QMS procedures?
  • What standards or procedures to follow for medical mobile app?

    My question is what standards, procedures our company should fulfill if we would like to design and develop medical mobile apps. Especially I am interested in design spec (UI/UX of interfaces) of those mobile apps.
  • Can the same set of documents be used for the new company?

    We have an old medical device company and it produces products right now and we open another one but its very far from the old one we can give it the same name of the old company and make this like extension,and if its okay and we going to produce the same products of the old one we have not to make a new technical file and documents for the new company ?
  • Clarification regarding customer communication

    Does customer communication (answer) following a complaint is a mandatory requirement per FDA or MDD. Can it be concluded from ISO 13485:2016, SEC. 7.2.3 (C) : "The organization shall plan and document arrangements for communicating with customers in relation to customer feedback, including complaints" ? or perhaps this paragraph is intended to state that as part of the complaint process we need to communicate with the customer in order to receive as much as possible adequate information and data related to the complaint event.
  • How to manage risk and clinical evaluation?

    quality management system and how can I manage risks and make clinical evaluation and I need to know what is the meaning of sterile barrier systems
  • Estimation of timeline for ISO 13485 certification

    We as a company are thinking about achieving 13485 certification. Is there a rough estimated time schedule on how long the certification process will take starting from zero? We have already looked into the ISO and implemented some processes, however for planning further steps we wanted to setup a timeline.
  • Is medical device file require for a supplier ?

    If I supply plastic injection molded clips to a medical device manufacturer am I required as a supplier to have a Medical Device file for these clips?
  • What should be question for getting feedback from production of product?

    8.2 Monitoring and measurement 8.2.1 Feedback As one of the measurements of the effectiveness of the quality management system, the organization shall gather and monitor information relating to whether the organization has met customer requirements. The methods for obtaining and using this information shall be documented. The organization shall document procedures for the feedback process. This feedback process shall include provisions to gather data from production as well as post-production activities.
  • Should the company be ISO 13485 certified while outsourcing assembly service?

    HI I am a 1 man band developing a medical product and was wondering if I need to iso13485 or can I get a company who is already iso13485 to do the assembly for me?
  • Change control management in Advisera Toolkit

    Our team is making progress on transforming your 13485 doc packet into our company QMS, but they have said "there is no mention of change control management". Can you tell me where this is in the packet?
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