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.

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.

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.