kak33

  • I think all undergraduate and graduate programs should considering adding courses like this because it gives students a glimpse of what it is like in the industry. My first job out of college as a R&D technical for a regenerative medicine company and I had no idea what design controls were, process validation or the various job opportunities. I…[Read more]

  • kak33 replied to the topic Non-Conformity in the forum Quality Systems Management 3 months ago

    A couple of weeks ago my company had to place product on hold and initiate a CAPA because of nonconforming product. At a high level, a custom component from a supplier was not made to specification and was used to make the final device. Thankfully, the bracketed product was not shipped to customers so we were able to quarantine all affected…[Read more]

  • In addition to internal audits to improve quality, my company also hosts internal kaizen trainings for various process to make continuous improvements. I have never heard of a kaizen until I joined this company but it is the Japanese word for “improvement”. In business, kaizen refers to activities that continuously improve all functions and…[Read more]

  • From my experience in the industry, this is a common problem in many departments. I’ve seen departments over loaded with work and the quality of the work that they are able to accomplish decreases. Sometimes people feel rushed and make mistakes. Sometimes people may try to cut corners.
    Additionally when teams are over loaded with work and r…[Read more]

  • The FDA anticipates publishing a proposed rule early in 2019 on aligning the two. The FDA was instrumental in the revision of ISO 13485, most of the Part 820 regulation requirements are covered in ISO 13485. However, there are some requirements that might not be included explicitly in ISO 13485, for example Device History Record (FDA Part…[Read more]

  • My company performs a yearly review of our manufacturing practices. However, I did find a publication by the NSF about changing your quality culture and improving GMP behaviors. It steps the reader through identifying what needs to be changed, what works and doesn’t work, and what motivates people. Additionally, it describes a unique five-step b…[Read more]

  • I think it can get tricky when talking about process revalidation and what is required to qualify the equipment to be used in the process. In my opinion, I don’t think you would need to revalidate the process in EVERY situation that you are relocating equipment. For example, if you are relocating a PC used in a predominately manual process, t…[Read more]

  • I think we can all agree that it is better to be proactive in MOST, if not all situations for the best interest of the business. I think it is also important to note that by definition one of the intentions of a CAPA is to prevent. I think it is up to the event owner/investigator and MRB to ensure that due diligence has been done to scope out the…[Read more]

  • I feel that my undergraduate career prepared me to write technical reports more than protocols. I am confident in my writing abilities, however, I still feel like it is always a good idea to get an independent person to review your work.

    In my short time in the industry, I’ve found that older engineers that have been in the industry for a while s…[Read more]

  • I think a SOP should be used during the research phase but if not, I think it MUST be used during development. This way the engineers would be able have some sort of traceability to know that the processes used and design elements used during research to know that whatever is transferred are equivalent. For example, at my job we wanted to change…[Read more]

  • In my experience, I add as much detail as possible to SOPs such that there is no room for interpretation because our processes are so tightly controlled. For example, right now I am developing a process to create Master and Vendor CD to ship to duplication vendors for software, media, or customer communication artwork. Much of the process would…[Read more]

  • I currently work as a manufacturing engineer at a medical device company. My team is responsible for maintaining the on market device. We use DCPs (Design Change Process) to make any changes to the device, including labeling. People who join our team from other companies really thing that our process is more tedious and elaborate. Recently the…[Read more]

  • My company doesn’t fill out a DSD. However, we do maintain a traceability matrix that shows all of the verification and validation activities completed for each design input. I think the level of up front detail that is presented with a DSD is very helpful to document necessary information required to effectively define product design and give t…[Read more]

  • I currently work in manufacturing and I see a lot of instances when a design and process needs some form of verification or validation. We use verification activities to test and confirm that product meets the specific requirements of the defined instructions. Typically we have in process checks to verify that specifications have been met during…[Read more]

  • I understand the idea of using the DHF as a living document to detail design and development plans and deliverables. However, at my company, once the product has been transferred, the DHF is sealed and any changes must be implemented via design change activities according to FDA Design Control regulations. From my understanding of regulation,…[Read more]

  • I found this article that relates to the topic. It digs a little deeper as to WHY it actually takes so long go get devices approved in the US. According to the article, Innovative medical devices take significantly longer to gain approval from the U.S. Food and Drug Administration because of administrative hurdles, rather than unfamiliarity with…[Read more]

  • Another notable difference is with post-market clinical follow-up. For the FDA, PMCF is only required for the highest risk devices. For CE Marking, however, all product families are required to have evidence of post-market clinical follow-up studies or a justification for why post-market clinical follow-up is not required.

  • There are differences in regulatory approach between the EU and the U.S.. Therefore; there are differences in device classification and we can not assume that meeting the requirements for the U.S. market would satisfy the EU requirements. Another example of a medical device that is classified in US and EU differently is hospital beds. According to…[Read more]

  • Beyond identifying a combination, I wanted to touch upon some of the challenges that surface when understanding the classification, and jurisdiction of these products. Common challenges include legal issues, marketing, premarket, post market, and cross labeling. Legal issues arise because there currently statutory or regulatory standards for…[Read more]

  • I am not very familiar with my companies marketing strategies. However, I do think we use a participation approach. At one of our all employee meetings last year a representative from the ER department of one of the largest hospitals in Ottawa came to speak. They hosted a 6 month trial with the use of our device and described their success, their…[Read more]

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