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 togethersolvers@gmail.com 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