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.
To help you, we have put together a free starter kit. With it...
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.
The e-book provides you with an introduction not only to the regulatory basics.
Benefit from our IVDR & MDR checklists and get all important information.
Like the IVDR, IVDD, MDD, MDR, MPAMIV, MPBetriebV, MPDG and MPG
Including IEC62304, IEC62366-1, IEC82304-1, ISO10993-1, ISO13485, ISO 14971, ISO15223-1, MEDDEV 2.7/1 Rev 4
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.