Getting an overview of regulations and standards is a headache for you?
We help you from the very beginning....

The Johner Institute Starter Kit

You are still at the beginning of your approval? An audit or inspection is coming up soon and quality management, regulatory affairs and development are getting increasingly nervous? Have you thought of all laws and standards? Are your documents complete? We are here for you! Download the Johner Institute Starter Kit now and get an overview of all necessary regulations and standards, so that you can quickly and safely approve your medical device.

Advantages of the Starter Kit - Your Quick Start in the World of Regulations

To help you, we have put together a free starter kit. With it...

  • you will find tips on how to interact effectively with the decision makers who will have some impact on how successfully you are able to bring your product to market in the EU and US.
  • you will learn the six steps to the "approval" of your medical device in Europe under the MDR, so that you can sell your medical device as quickly as possible.
  • you can check whether you have thought of all legal and normative tasks in preparation for your audit or inspection. This will help you avoid costly rework, embarrassing complaints and project delays.
  • get a quicker overview of the contents and save yourself the time and frustration of researching laws and standards.
  • You will understand the US reimbursement system and define your own strategy for your medical device

The contents of the starter kit

E-book "Market access in the US"

The e-book provides you with an introduction to all relevant stakeholders e.g. FDA. It will help you to define your strategy to bring your medical device to market in the US and even provides guidance on reimbursement.

E-book "Market access in the EU"

The e-book provides you with an introduction not only to the regulatory basics.

Checklists

Benefit from our IVDR & MDR checklists and get all important information.

Info on laws, directives, and regulations

Like the IVDR, IVDD, MDD, MDR, MPAMIV, MPBetriebV, MPDG and MPG

Info on standards and guidelines

Including IEC62304, IEC62366-1, IEC82304-1, ISO10993-1, ISO13485, ISO 14971, ISO15223-1, MEDDEV 2.7/1 Rev 4

Medical Device Briefings

The Johner Institute's newsletter keeps you updated on changes affecting the medical device and IVD industry. Get best practices and industry insights for better medical device quality, compliance, and product development.

Your personal starter kit - request easily!

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