At Innovision, we know the medical device industry.
Innovision, Inc. offers the essential competencies (Program Management, Quality Systems, Regulatory, and Remediation) to support your Medical Device business. We recognize that all companies have a unique journey as they grow and mature, so we tailor our relationship with you to meet your specific needs.
Let us help you overcome seemingly endless hurdles of quality requirements, regulations, and ambiguous project plans that never seem to be met!
Program Management
Create and implement a Product Development Process (PDP)
Create and manage program plans that are aggressive and predictable
Manage development teams to meet time and cost goals
Provide leadership and communication throughout organization
Quality Systems
Create, implement, or improve a Quality System that is efficient, that works for you, not against you, and is robust against audits
Regulatory
Ensure compliance with all applicable Regulations
Establish Regulatory procedures
Ensure Regulatory Strategy is in alignment with Business Strategy
Remediation
Warning Letters, CAPA Backlogs, Design Control Documentation, and more can, be onerous and disruptive. Let Innovision help you with these.