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Evolving QMS system of home blood test kit
We need to evolve a QMS system of our home blood test kit, which included a specimen collection device. We need to produce a Declaration of Conformity and be CE ASAP. What is the quickest way to go about this?
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Regulatory requirements applicable for Ventilators
What are the regulatory requirements applicable for Ventilators?
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Risk based approach in ISO 13485
1. Has there been a noticeable improvement with the implementation of 13485:2016 with the risk-based thinking approach?
2. What must companies do in advance to prepare for the stringent requirements in Eu MDR handling of complaints?
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ISO 13485 for outsourced supplier – is it necessary?
Hello, I am a Auditor/Consultant and I have a client that is a outsourced supplier (Specialized Outsourcing Services, integrating the assembly of electronic boards, wiring harness and electronic equipment) who works with several MD companies, but without any finished product and he has no Design and development once all production is done under client specifications. He asked me to determine if ISO 13485 was a good option for his company once his scope is only on production involved in one or more stages of the life-cycle of a medical device and he is already ISO 9001 certified. ISO 13485 is mainly for finished product suppliers so it´s no mandatory for this client, but there can be some interesting point evaluating if it is a good option. I must present an overview /report to support management decision about ISO 13485 certification or not. If they decide to go on certification, do you have a solution for this?
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Is written procedure required for internal Audit if audit is outsourced to outside consultant?
Hi, Is it required by ISO 13485 to have a written procedure for "Internal Audit" if the company always hires a qualified consultant from outside the company to perform the internal audit? No one internally. Always outsourced for internal audit (once a year).
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Which aspects of MDR compliance should be main priority?
With a wide range of products and limited resources which aspects of MDR compliance should be the main priority?
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Necessity of team training in Good Manufacturing Practices
Is it essential to keep the entire team trained in Good Manufacturing Practices?
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Does your toolkit have any policies or appendices that surround FDA ESG or Digital Certificates?
Does the ISO 13485 Toolkit have any policies or appendices that surround FDA ESG or Digital Certificates? -
Labeling Instruments with calibration information
Hello, I was wondering if you could show me in the ISO regs where/if it states that an instrument needs to be labeled with a sticker stating the day it was calibrated and the next time the calibration is due? -
MDR Medical device documentation for distributors
Firstly I should introduce myself. I am Compliance Officer for *** based in the UK. *** are distributors of medical devices and have a vast range of products acquired from our list of approved suppliers. We, as an organization have been authorized by our suppliers to ensure that all products meet the MDR standards and, to document and submit these products to the *** website. What I need to know firstly, is what documentation I need to put together for each product, such as certificate, instructions for use etc…. We as an organization are already ISO 9001 accredited so do not need to undertake another ISO accreditation. Is there a specific list of documents required for each product? I am taking this is phases, and phase I will be to pull all documentation together. Phase II to establish the class of products and finally Phase III to submit to the website.