They need to be reviewing the regulations and their product development process, asking where they need to make changes and whether they need to hire someone to help. Many may consider budgeting for a consultant to conduct a gap analysis, develop action plans, assist with training and even conduct mock audits.
The positive aspect is that small companies are more flexible and can adopt changes relatively quickly. A large company with in-house resources won’t necessarily have the innovative ideas of a hired consultant who has experience with many different European medical device companies, as opposed to just one to two. Smaller companies can leverage that expertise and implement those changes to sustain or even improve their market positions.
