Contract Development Services
TAILORED DEVELOPMENT SOLUTIONS TO ENABLE YOUR INNOVATION
OUR EXPERTISE ENABLES YOUR INNOVATION
Our team of medical device design engineers, project managers, and manufacturing engineers have the knowledge and solutions orientation you need to get to market faster.
DESIGN & DEVELOPMENT
We combine tailored development services with high quality, cost-effective manufacturing processes to deliver your product on time and on budget.
Design for Manufacture
CAD Design
Drawing Creation
DXF Creation
Process Development
XLerator Day (Remote or On-site)
Reverse Engineering
TOOLING & FIXTURING
From the early stages of your product concepts, we collaborate purposefully and focus on your goals so we can best support design choices, offer advice on manufacturability, and provide quick-turn samples.
RAPID PROTOTYPING
Whether you’re dealing with a blank canvas or a tight production timeline, we can help accelerate your time to market. We eliminate waiting and streamline logistics via our XLerator program. We offer dedicated remote or on-site access to our team of project engineers, process development engineers, manufacturing technicians, and machine operators to mock up actual parts and turn four to eight design iterations in a single day.
DOCUMENTATION
From inspection to certification, we manage the foundational documentation you need to reduce risk and enhance reliability.
New Drawing Revision Process
Certificate of Analysis
Material Certification
PFMEA
PFD Inspection Protocols
VALIDATION
We customize verification and validation master plans and supporting protocols to establish with a high degree of certainty that your process consistently works.
REGULATORY
We’re highly invested in your success, and we provide a level of attentiveness you won’t find elsewhere. You can trust our team of experts to help you comply with all applicable regulations.
Letter to File or Other Regulatory Filings
Private Label & IFU (U.S. Only)
Private Label & IFU (C.E. Only)
Notified Body Review for Private Label
