If you’re just beginning the approval process, facing an upcoming audit or inspection, and feeling the pressure from quality management, regulatory affairs, and development, this kit is for you. You’ll be well-prepared to swiftly and confidently approve your medical device.
Advantages of the Starter Kit - Your Quick Start in the World of Regulations
- Decision Maker Interaction: Get tips on effectively engaging with decision makers who influence your product’s success in both the EU and US markets.
- Approval Process: Learn the six steps for obtaining approval for your medical device in Europe under the MDR, allowing you to sell it quickly.
- Avoid Mistakes: Check off legal and normative tasks to prevent costly rework, embarrassing complaints, and project delays during audits or inspections.
- Time-Saver: Quickly grasp the essential contents without spending hours researching laws and standards.
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
Includes the EU directives (IVDD, AIMDD, MDD) and the current EU regulations (MDR, IVDR) as well as national law (e.g. 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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