Digital Transformation:
The Disruption of Your Regulatory Affairs Processes

The solution to the biggest problems: agonizingly long approval times, dull diligence and a worsening skills shortage

Most regulatory affairs departments suffer from the same problems:

  • They struggle with incomplete and inconsistent technical documentation (TD) and must constantly beg for support from other departments. 
  • They have to do repetitive and dull busywork like compiling regulatory dossiers for different markets.
  • They suffer from a lack of applicants interested in such activities.
  • They waste unnecessary time in tedious coordination with Notified Bodies and authorities, as well as in antiquated and laborious sending back and forth of countless documents.
  • You lack clarity about their exact requirements.
  • They struggle with unplannable and unacceptably long approval times.

Do these problems sound familiar? Then arrange a free, no-obligation consultation with us. We will show you the way out of this situation.

Book a non-binding and free consultation

Problem solver digital transformation

Digital transformation helps you solve these problems:

  • It automates diligence work and relieves you of up to 80% of your work.
  • It speeds up the approval process by automatically detecting errors in the documents (before the Notified Body does) and also relieves the Notified Bodies through automation.
  • It creates modern and attractive jobs for regulatory affairs managers.

The future has already begun

Digital transformation is not a dream of the future. The Johner Institute is already supporting medical device manufacturers, authorities and notified bodies:

  • Enterprise Software
  • The Software as a Service already takes over many tasks such as the
    • Regulatory Monitoring (that's thousands),
    • Post-Market Surveillance,
    • preparation and review of technical documentation, and
    • Submission of approval documents to authorities and notified bodies.
  • Supporting your digital transformation
  • Johner Institute's regulatory and digital experts can help you,
    • Define digital transformation goals specific to your business,
    • Determine company-wide aligned data models,
    • Align and adapt your existing tool landscape and eliminate silos,
    • optimize your regulatory processes and
    • Determine the digital transformation effort and plan the transformation process.

Sign up for a free, no-obligation consultation. Then you'll know exactly how to successfully transform your regulatory affairs function to create 

  • secure and attractive jobs and 
  • a company that will remain competitive in the future.
Book a non-binding and free consultation

Privacy settings

We use cookies on our website. Some of them are essential, while others help us improve this website and your experience.