IVDR is the new In-Vitro Diagnostic Regulation for the European Union. So what should you expect from it? How can you be ready? What are the elements to take care of? I will tell you everything on this podcast.
The UDI is one of the new innovation that comes with the new Medical Device Regulation MDR 2017/745 and also the IVDR 2017/746. On this article I tell you what you need to understand how to implement this new tool.
Are you a beginner on Medical Device Audits or Regulatory Compliance. Anyway, I present you a case study on how you can prepare yourself for an Audit.
MDSAP is the new Medical Device Single Audit Program. Some countries agreed to join the effort to harmonize their regulation so manufacturers can be audited only once for all the countries on this program. Learn on this article how to pass this audit and understand how its working so you can succeed.
I also included a podcast interview I have made with Angelina Hakim from Qunique about MDSAP.
The European Union decided to update the Medical Device Directive 93/42/EEC to the new Medical Device Regulation 2017/745. What are the changes? I’ll explain you everything on this article
A new obligation to perform an unannounced audit with Medical Device manufacturer created a lot of problems to any notified body. Resources not available, tight timeline. It is not easy for them but also to Medical Device Manufacturers.
Learn the DICT methodology to perform a Merger & Acquisition compliance review for a Medical Device Company. 3 Steps critical for a successful M&A.
Compliance is one of the aspects that are not well performed when taking over a new company.
