Innovenn

Innovenn delivers end-to-end support for SaMD and digital therapeutic development. The services include concept definition, clinical evaluation, usability engineering, regulatory strategy, and post-market planning, tailored to align innovation with compliance and user-centered design throughout the digital health lifestyle.

The platform guides device development from early feasibility through design verification, validation, and regulatory submission. It supports discovery and concept development, technical writing, risk management, and coordination to efficiently navigate approval pathways and launch medical devices globally.

Innovenn’s innovative spirit, combined with Improvita’s expertise in human factors research, iterative testing, summative validation, and user-centred design consulting, enables the development of products that meet both regulatory standards and user needs. This approach maximizes safety, effectiveness, and usability.

The system works with several disciplines associated with the path to marketing approvals for chronic and rare disease management. It develops integrated regulatory strategies aligned with clinical, business, and commercial objectives. The platform manages the preparation of New Drug Applications (NDAs), 510(k), PMA, and global submissions to support successful regulatory approvals worldwide.

Innovenn delivers comprehensive QMS consulting, including gap assessments, policy and workflow development, and audit preparedness. Services encompass mock audits, Corrective and Preventive Action (CAPA) support, documentation controls, and corrective action planning to maintain regulatory compliance.