As the summer holiday season begins to draw to a close, teams across the medical device industry are gradually returning to their usual routines. At MDS, the summer months have remained active. While project schedules may look different during the holiday period,...
For European medical device companies, entering the US market often requires adjusting to a different regulatory system. The FDA pathway has its own terminology, submission routes, inspection expectations, and post-market requirements. Even companies with mature EU...
Internal audits are sometimes treated as a routine requirement. Something that needs to be scheduled, completed, documented, and closed before the next external audit or certification milestone. In practice, they can be much more valuable than that. A well-conducted...
