Going International

According to a recent survey, most of the companies nowadays consider going international a key process to increase business. The internationalization process is not easy for a company. You will lose people when going international (mostly because adaptation issues), your treasury will go through an endurance test and you will need to develop skills that were not needed before.

But the most important issue of going international is to make it right from the beggining. Follow the right steps is mandatory, and finding the right partner to do it, is even more important. I have seen many companies deciding on where, how and when going international without taking into account regulatory issues, cultural differences or even macro conditions of the market.

Which are the right order of the steps to be taken? 1.- Select the country 2.- Select how you will get into the country 3.- Determine the internal estructure changes to be made 4.-  Asses the degree of adaptation or standarization needed on each country 5.-Prepare a focused business plan for the country

This are the core activities from where many other evolve. Again, when deciding to go international, get the right partner that can support you.

Changes On CE Marking Medical Devices

Notified Bodies will audit and supervise the manufacturers differently in order to obtain  CE marking certification from 2014.

Two documents published by the EU Commission install a  tighter regime of audits and technical documentation assessment on manufacturers of medical devices.  The two Commission documents are:

  • Commission Implementing Regulation (EU) No 920/2013 on the designation and the supervision of Notified Bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.
  • Commission Recommendation on the audits and assessments performed by Notified Bodies in the field of medical devices 2013/473/EU.

How this rules will effectively change the way manufacturers will implement CE marking is still to be known