https://www.youtube.com/embed/lR4r14V5oHA?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The CAPA system is an important pillar of your Quality Management System (ISO 13485 or FDA QSR) and we have identified a lot of issues that companies are doing with it.

For this episode, I have invited Stefan Bolleininger from Be-On-Quality so we can discuss this topic and share with you our experience.

CAPA means Corrective Action Preventive Action and is used when an issue is identified. But there are many parameters to do a good CAPA and there are also some good practices to avoid to show the wrong one to an auditor.

Let us know if you were in the same situation and what you have done to correct it.

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Can you imagine arriving at a Hospital and telling you that they cannot plan a surgery because there is disruption on the delivery of a product? I am sure you are thinking this is impossible. But we already talked of this possibility with the upcoming Medical Device Regulations (MDR 2017/745 & IVDR 2017/746) and the Manufacturer’s difficulties to comply with it.

Let’s ask then Stefan Krojer who was working at the Berlin Johanniter Hospital as responsible for procurement. He had to manage some difficult situations and provide his expertise and some solutions.

He decided to start a new initiative where he collaborates with a Startup to develop a platform that will connect Hospitals with medical device manufacturers or distributors to reduce the number of disruptions. Learn more about it in this episode.

Stefan Krojer is an experienced hospital procurement and supply chain manager.

With his blog “Future Hospital-Procurement” he is looking for more transparency and dialogue between the partners in hospital procurement.

His specialty is digitization, innovation, and collaboration. His study “Future Hospital Purchasing 2025” has shown that the buyer of the future needs to standardize and digitize all his own data and processes. In order to activate the role as a game-changer, he must find new solutions with the help of external value creation partners and internally implement them successfully.

As a connoisseur of corporate goals, you not only buy products, but also new market and business opportunities.

• Stefan Krojer’s Linkedin: https://www.linkedin.com/in/krojer/

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Start-Ups are really doing great to develop the Medical Devices that patient needs but they should satisfy Investors and also Regulators. This can create some situations.

This is why Justin Bushko will share with us his experience with Start-Ups by listing 5 FDA Myths. I am sure you’ll recognize some of them as maybe your company experienced that.

At the end of the show notes, I will also provide you a link to download a document that summaries our discussion with Justin. This can be helpful if you want to teach your team about some of them.

Justin Bushko, Principal of Concise ENGINEERING, holds a BS in Electrical Engineering from Grove City College and an MBA in Leadership & Management from the University of South Florida. CONCISE offers support in Program & Project Management, Electrical Product Safety and Usability in the Medical Device Industry.

Concise also offers support to Start-Ups focused on the development of embedded systems. Justin has provided New Product Development solutions to industry for the last 20 years. He has led design teams to launch or sustain over 100 products.

Additional certificates include Project Management Professional (PMP), ASQ Software Quality Engineer, Six Sigma Black Belt, Design for Six Sigma, Lean Design, Kaizen and Root Cause Analysis.

• Justin Bushko Linkedin: https://www.linkedin.com/in/bushkojustin/

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GDPR is a well-known regulation now that is impacting all sectors as this helps to keep your data protected. So this also means that the Medical Device product should comply with it. But how to do that?

Jovan Stevovic is the CEO of Chino.io. He will help us to understand “What is GDPR?” and the link between GDPR and MDR 2017/745.

If your products are not compliant to GDPR, you can be heavily fined by the European member states so better understand it and put in place a strategy to protect the data of your customers or users.

But what are the elements to consider to be compliant to GDPR? and who should be on your project to support it and be sure that you are translating correctly the GDPR requirements to your design? This topic is really difficult as any miss can make your product not compliant. And the cost to be GDPR compliant can also be increased if you have not considered that from the beginning of your development.

Jovan Stevovic, Ph.D., is the co-founder and CEO of Chino.io, a platform that makes health applications GDPR and HIPAA compliant “out of the box”. Jovan has over a decade of experience in the health IT industry. He completed his Ph.D. at the University of Trento in 2014.

His research explored technologiesand protocols to allow health data to be shared in a legally-compliant andsecure manner. This work directly led to setting up Chino.io. 

Currently, Chino.io helps companies in most EU states and the US to innovate in digital health.

• Jovan Stevovic Linkedin: https://www.linkedin.com/in/jovanstevovic/

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The challenge for Medical Device companies is to understand the different pathways to register their products in a certain region. On this episode, we will focus on the US FDA regulation for Medical devices.

To help us, I invited Michelle Lott from LeanRAQA. She will let you know what are the different steps to consider when you are trying to register a Medical Device in the USA.

We will talk about the product classification, the different registration procedures (510k, deNovo, PMA) and also about the Quality Management System acceptable by the FDA.

After listening to this episode, you will have a minimum understanding to place your product to the US market. But anyway if you need support you can contact Michelle or me to answer your questions.

Michelle Lott is founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!).

She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries. She has a weakness for tequila and anything barbecued.

• Michelle Lott Linkedin: https://www.linkedin.com/in/michellelottraqa/

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