Together Solvers LLC

Engineering and Management Consultant for the medical device industry with over 28 years of experience in both start-up and established companies. I help clients accelerate product development by quickly identifying and plugging gaps in their development execution or strategy. What sets me apart from other consultants is that I enjoy getting hands-on to not only advise, but "to do". This includes any element of product development, from early-stage concept testing through post-launch optimization. With over 50 product launches under my belt, my background allows me to rapidly deliver high quality deliverables with very little training and oversight. Email Steven Robertson at [email protected] Service offering examples: Research and Development (R&D): - Specification development - Concept / feasibility studies - Design verification, design validation - Human Factors - Biocompatibility and Preclinical studies - DHF and filing documentation / compliance to standards - Due diligence Project Management: - Direct Project / Program Management - Broken / delayed projects - Project kick-off and planning - Project schedule optimization - Establishing a PMO - PMO best practices, culture, and metrics Operations: - Process development and validation - IQ / OQ / PQ - GR&R - Contract manufacturing oversight and contract review Quality and Regulatory: - Risk Management (DFMEA, PFMEA, URRA, Risk Benefit) - FDA PMA and Breakthrough products - Maneuvering through complex quality and global regulatory requirements - Crisis management Executive Leadership: - R&D, Project Management Office, Operations - Start-up support - Interim support - Flexible to a variety of financial arrangements and partnerships Technologies include: Neurovascular, Cardiovascular, Peripheral Vascular, Active Implantable, Stents, Coils, Intrasaccular Devices, Catheters, Guidewires, Balloons, Liquid Embolics, DBS, IPG and Leads, Wound healing, Oncology, Ophthalmic

• Employees 1
• Founded 2022