Expert Sessions

Expert sitting with headset in front of two computer screens

Your direct path to effective solutions

Our Expert Sessions – Your Benefits

Answer specific questions in intensive working meetings and use the results immediately for your project success and achieve regulatory excellence through targeted knowledge exchange:

Immediate applicability

Work within your team to develop results that can be incorporated directly into your ongoing processes without delay, rather than ending up in a drawer.

Real-world expertise

You will speak to consultants who have first-hand knowledge of the regulatory reality and who support companies on a daily basis with audits, approval procedures and implementation projects.

Interactive collaboration

Benefit from the dynamic of a guided working meeting in which our experts combine theory and practical experience for your specific core topic.

 

Communication at eye level

We understand your challenges and speak your language. We engage your team to turn complex regulatory requirements into clear, jointly supported solutions.

Highest efficiency & quality

Focusing on your core issue enables you to achieve in-depth results in a short period of time. In a small, interactive setting, we address your regulatory questions in a targeted manner, thereby increasing both the speed and quality of the solutions.

Immediate availability

We offer appointments at short notice – ideal when deadlines, audits or internal milestones are approaching and you need immediate regulatory support from experts.

 

Secure your appointment for an expert session now using our contact form​​​​​​​ and get your project moving forward!

Your Partner for Making Informed Decisions

We offer you more than just a consultation session. We provide medical device and IVD manufacturers with comprehensive support to help them overcome regulatory hurdles:

  1. Compliant regulatory solutions: We help you clarify your project-specific issues so that your documentation ultimately complies with legal requirements such as the MDR or IVDR.
    ​​​​​​​
  2. Tailored expert input: Our expert sessions offer you direct access to specialised know-how to efficiently overcome your individual regulatory challenges.

Our more than one hundred top experts, who participate in standards committees, audit notified bodies and work with the FDA and European authorities to improve the regulatory system, also contribute to our success.

Let's Achieve Your Goal Together!

Whether you need initial guidance, validation of your approach or a deep dive into a specific topic, you will receive exactly the input you need for your project phase. In a one-to-one online session, you can speak directly with our experts and ask your questions on topics such as:

  • Conformity assessment procedures for medical devices
  • ​​​​​​​Quality management systems (e.g. ISO 13485, 21 CFR Part 820)
  • Software as a medical device and digital health applications
  • Risk management
  • Labelling and instructions for use
  • UDI and EUDAMED
  • Electrical safety and EMC

You bring your specific concerns – we bring the relevant expertise of the Johner Institute.

Who are the sessions aimed at?

The expert sessions are aimed at companies and organisations that want to clarify regulatory issues quickly and in a targeted manner, in particular:

Manufacturers of medical devices Start-ups and innovative medtech companies Authorised representatives, distributors and importers Hospitals and service providers with regulatory clarification needs

How Your Expert Session Works

01

Focused preparation

Send us your questions and documents two weeks in advance. Our experts will thoroughly examine your individual query.
02

Intense work meeting

In a three- to four-hour online meeting, a small team focuses intensely on your core topic.
03

Direct dialogue with experts

Enter into direct dialogue with our specialists. We will answer your questions comprehensively and without delay.
04

Maximum results

With our structured format, you will achieve maximum results in a short period of time.
Any questions? Get in touch!
Phone Icon

Phone

+49 7531 94500 20

Contact Form Icon

Contact Form

X

Privacy settings

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