Are you planning to develop a medical app? It is crucial to understand what is involved in certifying software as a medical device. This requires implementing a quality management system (QMS) and preparing a technical dossier, both of which must be certified by a "notified body" through formal audits.

Despite certification costs, CE certification offers essential advantages:

• Access to the European market
• Guaranteed quality
• Opportunities for reimbursement
• Minimization of business risks through validation

It is critical that health app developers develop both a product development and regulatory strategy in a timely manner. The MDR allows regulatory tasks and technical product development, marketing and sales to be separated and handled by different organizations. This means you can decide to outsource certain tasks.

Read more in the article: https://www.ntvl.nl/journal-article/levensveranderende-code-navigeren-door-de-regels-van-medische-software/