Total Project Management!
We are ready to handle any of your Medical Device Development and Project Needs
From Ideation to Design Transfer, we incorporate best practices into our processes and focus on the correct phase and activities —at the right time!
Our expert Innovation Consultants will guide and mentor you through all aspects and obstacles of Product Development
Our experienced Biomedical Engineers will design and/or develop your whole product or any aspect of your product to the highest standards
From technical guidance to complete project management, we provide the right services at the right time!
Koven’s cardiovascular innovation will guide you through the barriers and move your project forward to the next milestone.
- We provide reliable, supportive, and effective outsource services that will lead you to success
- You will meet your deadlines faster
- We apply high levels of experience and expertise in short time intervals, saving you time and money
- We understand where you’re at and where you need to be
- Our experienced and friendly engineers are committed to your success
We perform all work according to FDA’s Good Manufacturing Practices, Medical Device Directives, Canadian Medical Device Regulations, ISO 13485, & ISO 14971
Our Services Include:
Have a dream? An Idea? A vision? We will make it a reality!
Is your acceptance criteria optimized? Are all your metrics resolved? We can help with DIS!
You need the right people doing the right activities at the right time to prevent harm.
‘Where the rubber meets the road.’ You have what it takes, let’s build it.
Everyone’s different. Your QMS should meet your unique needs.
From a little to a lot… we will ensure you get there.