Implementing regulatory monitoring

I am a medical device manufacturer. Must I set up a regulatory monitoring system within my company?

Yes, it is a regulatory requirement, which also has many advantages.

Nex’inform allows you to:

  • Have an edge in your market;
  • Save time in anticipating and making the right decisions;
  • Find your way amongst all regulatory documents, guidelines, regulations, standards, guides you need.

Nex’inform comes in four quarterly phases:

  • You receive a list of standards and regulations with which your products must comply;
  • You receive a personalised assessment;
  • A summary that show you exactly where you are;
  • Suggestions for the standards you might need;
  • If a major standard has evolved, you also receive gap analysis to save your team’s time.

Nex’inform is also:

  • A specialist team at your service;
  • Guarantee of being “up-to-date” with your products and during audits by “authorities”, your customers…;
  • Clear and simple documents directly usable by your teams.

What are the risks if your regulatory monitoring is not effective?

Any organisation that does not meet the regulatory requirements may lose the compliance of its products with the regulations and therefore have its products taken off the market.

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