Regulatory advisory for Medtech
About the service
Norway Health Tech offers a three-part service that provides companies with the necessary knowledge and expertise to prepare technical documentation for the development of medical devices, thereby facilitating market access in key global markets.
Description
Training and Networking for Regulatory Requirements in Medical Devices
By understanding the requirements and assessing your own progress, you will gain the confidence to lead your team and collaborators through the process – and work more effectively with consultants. The service is delivered in three steps:
💡 Step 1 – Mapping
Evaluate, in collaboration with the company, its readiness, target market(s), the product (medical device), and the organization’s knowledge and experience in preparing technical documentation for medical device development.
📖 Step 2 – Understanding Requirements and Guidance Documents
Strengthen the company’s understanding of the key elements needed to prepare the required documentation, including identifying gaps and developing strategies to address them.
📝 Step 3 – Managing Regulatory Compliance for SMEs
Support the company in understanding essential tasks and in preparing effective documentation for regulatory compliance, as well as acquiring the knowledge and competence needed to manage the process of entering key global markets.
Our team
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