Thank you for watching.

Good luck on your job interview.

Best of luck!

Thank you. I have been teaching this since 2005. The video is our #1 most popular video, but it is 3 years old now. Any suggestions for a remake would be greatly appreciated. I'd like to know how to improve it. What's missing?

You're very welcome. Good luck with your training.

Glad it was helpful! The AAMI Practical guide might be helpful to you as well as a resource.

You are welcome! We are excited to hear that you feel empowered by these videos, and I hope that you can maintain that energy for a long and successful career!

Thank you. Please stay tuned to our channel. We are going to be updating 100% of our procedures in 2024. SYS-029 for FDA Medical Device Reporting is being updated tonight, and our complaint handling procedure (SYS-018) will be next (late December). We are also considering implementation of an eQMS for our turnkey quality system customers. That will make it much faster for people that purchase our turnkey system--even if they don't want the eQMS, because we can use the MS Word Style features to more quickly change logo, company name, etc. We are also going to change all of our procedure revisions to the format used by software revisions (i.e., 0.2 for the second draft, and 1.0 for the initial release). We will do some polls to get feedback on some other preference items (e.g., SYS-xxx vs. SOP-xxx).

Last week I posted a new webinar on software validation on our channel - kzfaq.info/get/bejne/hrxigZpk1K-lkac.html. Other topics that you should master are: 1) design controls, 2) design changes, 3) risk management, 4) cybersecurity, and 5) human factors.

@@MedicalDeviceAcademy Thank you so much, are these also useful for process engineering? Any tips on how to learn the IQ OQ PQ steps?

What a great question. There are two philosophies and both have merit. Option 1 - train first and then approve. This will ensure that people being trained have an opportunity to give you feedback on things in your revised procedure that are not clear. Option 2 - approve first and train second so people are only training on approved procedures. This also gets the new procedure into effect quicker.

That's actually a great question. I have seen companies with as few as one person implement a quality system, get MDSAP, 510(k) clearance, and get CE Marked. However, the companies that are that small need to rely upon contract manufacturers heavily and they rely upon our firm to help with independent reviews, internal audits, management reviews, etc.

Yes, specifically the 2016 version.

It is common to hear it referred to as "Thirteen Four Eighty Five"

Hi James, Our company offers a turnkey quality system, but the certification body recommendations depend upon the markets you are interested in. For contract manufacturers and companies only interested in the USA, we have been very happy with Eagle Certification Group: www.eaglecertificationgroup.com/ However, Eagle is not a Notified Body or an MDSAP auditor. Therefore, you would need to select from the NANDO database for Notified Bodies or the Health Canada/FDA list of MDSAP certification bodies. The UKCA market approval will complicate things further. Currently, only BSI, SGS, and UL are approved bodies in the UK. TUV SUD and DEKRA have applied, but they are not approved yet. If you only need CE Marking, and you don't need the UKCA, we have been happy with DNV and LNE/GMED for smaller device companies.

@@MedicalDeviceAcademy thank you. If I can email you to provide a bit more information would be great. I have CE support. Development of facility around iso is my interest.

I assume you are referring to fees for certification. The fees are specific to the certification body. Certification bodies that are not Notified Bodies (NB), such as Eagle Certification Group, are usually the least expensive. We recommend these certification bodies for a contract manufacturer. However, if a contract manufacturer selects a NB for a certification body, then they may also be able to avoid some of the annual supplier audits by NBs. If you are a manufacturer that is interested in Canada as a market, then MDSAP is necessary. This will limit you to 15 possible certification bodies, and only about 11 of them are also NBs. These are generally the most expensive certification bodies and the cost of MDSAP certification is about 2x the cost of a certification body that does not do MDSAP or CE Marking. The cost of initial MDSAP certification is about $30K (and going up all the time). CE Marking is a separate fee on top of your ISO 13485:2016 certification. The ISO 13485:2016 certification will typically be quoted along with your technical file review, and the combined fees can approach $100K.