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Services
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Our pricing model is so unique, nobody can match it!
- Because we are also an OEM, and have our own products, we can leverage our resources optimally.
- We have had to invest in regulatory compliance, supply chain management, engineering, manufacturing operations and logistics for our own products.
- You can leverage the best quality system, the best team, and the best infrastructure that we demand for our own product, without paying for ANY resource that you do not use.
Strategically, we decided not to charge any profit to our contract manufacturing customers because our own products benefit from sharing our resources' utilization with you.
In other words, because we do not need 100% utilization of all of our resources 100% of the time, you are helping us lower our costs for our own products, making them more profitable for us!
The result? You benefit from an Activity-Based Costing which we do not mark-up whatsoever (open book); yet you benefit from a team that we carefully recruited and that we trust to design and manufacture our own products.
Engineering and Prototyping
Our management team has extensive experience designing and engineering elegant solutions and has spent entire careers in the medical device industry, working from small startups to large multinationals.
Design and engineering in medical device industry requires understanding the regulatory requirements of the Industry.
Our experience is invaluable in assisting you comply to Federal and international regulatory requirements. In addition, due to our best practices and our network, we will deliver prototypes in record time.
Assembly & Testing
We manufacture and assemble your devices in our 50,000 square-foot FDA compliant, ISO-13485 certified facility in Auburn Hills, Michigan (USA).
Every square foot of our facility is temperature-controlled, and products are assembled and tested in a true medical grade manufacturing environment.
Clean room assembly is also available if the particular product we assemble demands it.
Logistics
We have an experienced team to coordinate your logistics needs. Let us worry about delivering your product to market in a faster and smoother manner without having to purchase container loads at a time.
We will synchronize your product delivery exactly when you need it, where you need it, and in the exact quantity required.
Lastly, volume has no bearing on us, since our pricing model is just our cost.
Supplier Management
For years, our leadership team has worked with economic development organizations to help diversify the local economy. This allowed us to gain deep awareness, knowledge, and unique access to an incredible domestic supplier base.
Our suppliers have years of experience working in highly regulated and demanding industries delivering excellent quality in the most cost sensitive industries.
For example, we have an unmatched access to the best automotive suppliers that are used to the most stringent requirements for quality, cost, and speed.
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- Manufacturing management and contract assembly of Class I and Class II medical devices.
- Unique business model enabling delivery of services At-Cost & Open Book!
- Over 25 years' experience.
- Incredible access to domestic supplier base.
- ISO-13485 certified and FDA compliant, 100% climate-controlled state-of-the-art facility, with clean room assembly.
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