Evaluate and improve business practices such as communication, office organization, file management, team structure, meeting management, etc. Reduce wasted time and resources.
Establish or improve cross-functional product development process (PDP) and functional procedures, develop high-performing functional excellence and business process maturity, provide team member and management training.
MedDev Consulting LLC can help you create design control procedures and/or design control documents as required by FDA under 21CFR820 and ISO 13485, as part of your quality management system. With over 20 years of industry experience with product development and quality systems, we can create the documents for you, work with someone on your staff to collaborate, and/or teach your staff the details and intentions of these documents as they apply to your product(s).
Establish project management processes and deliverables, train team members and management for business improvement or to prepare for project management certification, provide project management contract services. We can function as your Project Management Office (PMO) to provide any level of project management support your organization needs.
External business relationship management, acquisition or merger due diligence and integration, co-development, venture capital investment milestones and project management, service contracting management (design/development, manufacturing, distribution agreements)
Establish or improve strategic planning and project portfolio management practices, provide strategic planning/portfolio management contract services, train business planning and management personnel.
Specializing in (but not limited to) the Medical Device industry.