1) Steps to CE Marking an IVD Medical Device
One of the most frequent questions we are asked is: how do you CE mark an IVD device? In this article, we will look at the steps that you need to take to obtain when CE marking an IVD device.
As the new IVDR comes on stream, we will continue to revisit and revise this article to ensure that it is up to date. Read the full article here.
2) Need A WDA? Read Our Step By Step Guide
There has been significant growth in the number of companies seeking a Wholesale Distribution Authorisation (WDA) in recent years. We have assisted many companies with every step of the process. Here, we outline a step by step guide for obtaining a WDA. Read the full article here.3) How To Prepare For A Pharmacovigilance Inspection
A pharmacovigilance inspection can be a daunting prospect for many companies. Since 2002 we have worked with countless companies to guide them through their inspections. We look at the measures that your company can take to be prepared. Read the full article here.4) How To Complete A Type I Variation
Type I Variations to a Marketing Authorisation are surprisingly difficult. The procedure that many people perceive to be a simple process can prove to be otherwise. This article looks at how to complete a type 1 variation and we will consider:- common deficiencies
- common validation issues
- the challenges posed by the eAF
- what to do when documentation is missing
- how to handle GMP variations
- what happens when a CEP is presented for an active substance instead of a GMP certificate