Quality

You need an eQMS but why. Let me tell you on this article why this is important and let me also help you on that. Contact us at the end if you are needing support.

Maybe you are thinking of building a cleanroom for your Medical Device industry. Then read that first to have a clear understanding of how much this cost and also all the maintenance to perform.

Internal audit is a tool that is available within ISO 13485 or QSR 21 CFR part 820. We will explain how to perform it the right way

Are you more validation or verification for your medical devices? In some cases you have no choice but in other cases you can decide. Let me help you for that.

The creation of a Quality Management System is not stopping when the documents are ready. We will share with you a 5 step process to create a QMS with Jason Lim from Stendard.

With the ODIAC method, I will help you to improve your situation to solve issues on your work area. The objective is to move from Correction to Prevention.

When you hear ISO 13485, you ask yourself a lot of question? So my challenge is to answer to them. This Medical Device Standard will have no more secret to you. I talk even about the price of an audit and how long it can take to get your certificate. You should not miss that. Provide me your questions on the comment section.

Step by Step guide to verify the accreditation of your Certification Body or laboratory. I will show you with screenshots which site you need to look for and how to select the best third party for you. I will show you a specific example to verify the ISO 13485 accreditation of your Notified Body.

If you are a Medical Device company, you should know what is a Quality Manual but do you really know what should be included. When I see Quality Manuals with 30 to 100 pages it give me a mix feeling. Is it to show-off or because their Quality System is complex. I teach you what is the minimum requirement following ISO 13485:2016 and also some option that you can add. But it should not be more than 20 pages and this is already a big number.

When you start to create your Quality Management System following ISO 13485 you ask yourself from where should I start. My first action is to identify the mandatory procedures that I should write and then create them. With this blog post I help you to identify these procedures and give you a Free template to start creating yours. Let’s start this journey.