Innovision
Innovision, Inc. specializes in supporting the medical device industry by offering expertise in Program Management, Quality Systems, Regulatory compliance, and Remediation. They tailor their services to meet the unique needs of each client, helping them navigate quality requirements, regulations, and project management hurdles to develop competitive medical products.
Industries
Nr. of Employees
small (1-50)
Services
Consulting to design and run product development processes, create and manage program plans, lead development teams, and align projects to business metrics.
Services to create, implement, overhaul, or streamline quality systems; provide quality and validation engineering and deliver training.
Regulatory strategy and preparation support for FDA and international submissions, standards compliance, and regulatory procedures.
Remediation services for warning letters, audit findings, CAPA backlogs, and deficiencies in design controls and documentation.
Consulting to design and run product development processes, create and manage program plans, lead development teams, and align projects to business metrics.
Services to create, implement, overhaul, or streamline quality systems; provide quality and validation engineering and deliver training.
Regulatory strategy and preparation support for FDA and international submissions, standards compliance, and regulatory procedures.
Remediation services for warning letters, audit findings, CAPA backlogs, and deficiencies in design controls and documentation.
Expertise Areas
- Program management for medical device development
- Quality management systems (QMS) implementation and validation
- Regulatory compliance and submission preparation
- Remediation and CAPA management
Key Technologies
- Design controls
- Quality management systems (QMS)
- Regulatory submission formats (PMA, 510(k), Technical File, Design Dossier)
- Human factors engineering