Regulatory Diagnosis
To clarify your strategy and increase efficiency
innovative healthcare startups and project leaders
MD101’s regulatory diagnosis enables you to define the regulatory status of your product and the impact of regulations on its market.
Our regulatory diagnosis enables you to:
- Identify the main applicable regulatory texts and standards.
- Establish the applicable CE and FDA marking procedures.
- Classify and justify the class of your device according to EU regulation 2017/745 or EU 2017/746 and FDA.
- Understand the main regulatory and standards requirements you need to comply with.
- Establish a regulatory roadmap to obtain CE marking and FDA clearance. It is important to define your regulatory strategy clearly, so that you can draw up a schedule and a realistic business plan to answer your potential investors’ questions.