Support for management and executives

This page is aimed at management, particularly executives at medical device and IVD manufacturers, notified bodies, authorities, and service providers responsible for regulatory and clinical affairs, quality management, and development.

Important tasks of management

The management tasks of these executives include, for example:

Information management

Collecting information from outside, keeping track of it, and taking the necessary measures. This includes information about

• regulatory changes,
• market trends (technologies, competitors, customers) and
• the company’s own devices (post-market surveillance)

Quality management and strategy

Better positioning of your departments:

• Initiating strategic projects (e.g., digitalization, outsourcing, restructuring)
• Defining regulatory strategies
• Contributing to the improvement of the QM system (e.g., during management reviews)

Resource management

Create the necessary preconditions:

• Selecting service providers and negotiating contracts
• Creating, securing, and monitoring budgets for the departments
• Ensuring the size and competence of teams of experts

Support for management

Many managers rely on the support of the Johner Institute. It supports management with or takes over tasks from them.

a) Outsourcing

Managers outsource regulatory activities and processes to the Johner Institute:

• Creation, compilation, and improvement of technical documentation
• Post-market surveillance
• Monitoring of regulatory changes
• Placing on the market (Johner Institut acts as the legal manufacturer)
• Systematic training and further education of own experts

Manufacturers also outsource roles such as QM representative, EU representative, or PRRC.

b) Consulting

Managers rely on the advice and opinion of the Johner Institute:

• Setting regulatory strategies (e.g., international authorization)
• Executive briefings

The views of the two board members of the Johner Institute are relevant for executives.

c) Software & digital transformation

The Johner Institute supports medium-sized and large manufacturers in the digital transformation of regulatory processes and quality management.

Its enterprise software supports all regulatory processes, such as

• creation and inspection of technical documentation
• approval with the Digital Approval Platform as part of the real-time compliance system
• post-market surveillance with the Post-Market Radar
• monitoring of regulatory requirements with the Regulatory Radar

As a manager, contact us right away. You will receive fast, discreet, and competent support.